cyrilzakka/clinical-trials huggingface dataset:
Effect of the Interaction Between the Type of Artificial Turf and Boots Model of Bone Health in Children Soccer Players

The number of turf fields has experienced an important increase in public and private facilities during the last years. This artificial surface will be predominant in any soccer field in the next years. Among turf fields there are many different types depending on their construction characteristics (with and without asphalted base, elastic base, rubber filling, etc.). Officially all types of artificial turfs should have similar stability and impact absorption characteristics. On the other hand there is a great variety of soccer-boots, especially for youth soccer players, similar to the football stars.

Many evidences support the fact that when a person exercises many different type of impacts-stimulus are necessary in order to stimulate bone and skeletal muscle systems. However, it is not known yet whether this effect can be extended or shortened depending on the type of artificial surface and soccer-boots used, or even more whether it could be more or less dangerous and/or provoke injuries/disagreement among the users. Little information is available in youth soccer player pointing in the same direction but still controversial. Furthermore, bone strength do not only depends on bone mass but on bone structure and microarchitecture. The cross sectional area, cortex thickness or trabecular density are important aspects of bone health. There are few studies on the effect of interaction between turf field and soccer boots on bone architecture of youth soccer players. This information is relevant for present and future health of adolescents practicing football and for all the organizations promoting this sport.

Due to the fact that turf fields are preferentially used by youth populations, it is important to know the real effects of the interaction between of different type of artificial surfaces and soccer boots on children bone mass development. Nowadays, there are no data and/or defined guidelines that can answer those unresolved questions, thus the main aim of the present project is to identify which turf field and soccer boots are the most adequate to optimize the acquisitions of bone mass in children soccer players.


Eligibility Criteria:
Inclusion Criteria:

* Both: Aged from 11-13 years.
* Both: Parental/guardian permission (informed consent) and if appropriate, child verbal assent.
* Specific for the control group: Subjects that do not perform more than 3 hours of physical activity per week.

Exclusion Criteria:

* Taking medication affecting bone.
* Non-Caucasian.
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects

This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
* Body Mass Index (BMI) between 19-29 kg/m\^2 (both inclusive)
* Minimum body weight of 65 kg
* Fasting blood glucose between 3.8-6.0 mmol/L
* Glycohemoglobin (HbA1c) below 6.4 %
* Non-smokers

Exclusion Criteria:

* Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
* Hepatitis B or C
* Subjects with a first-degree relative with diabetes mellitus
* Known or suspected allergy to trial product or related products
* Smoking during the past three months
Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus

To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.

Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) were divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures were pre- and postoperative uncorrected distance visual acuity (UDVA), best corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry.

Eligibility Criteria:
Inclusion criteria

* age 34 (range from 34 to 41)
* stable corneal topography and refraction for at least six months
* estimated residual bed thickness of \>410 µm

Exclusion

* presence of macular or retinal disease,
* dry eye
* history of recurrent corneal erosions
* anterior segment abnormalities
* unstable refractive error
* post-surgically residual stromal bed thickness of under 350 mm
* autoimmune disease
* collagen vascular disease
* immunosuppressive therapy or current use of systemic corticosteroids
* diabetes mellitus
* pregnancy
* lactation
Testing the Efficacy of Safe South Africa

In this study, investigators will examine the efficacy of Safe South Africa, a behavioral intervention that is developmentally- and gender-tailored to prevent human immunodeficiency virus (HIV) and intimate partner violence (IPV) among adolescent boys. South Africa faces some of the highest global rates of HIV and IPV with sustained high incidence of HIV and alarming rates of IPV among adolescents and thus, is an ideal site to advance prevention science to tackle these urgent public health priorities. Testing the efficacy of an integrated intervention to prevent HIV risk behavior and IPV for adolescent boys can support optimal health for young people, their future partners, and society.

Adolescence presents an ideal developmental transition period for an integrated intervention targeting prevention of HIV risk behaviors and intimate partner violence (IPV), including sexual violence. Adolescent boys in particular are at high risk for HIV and perpetration of IPV. Yet, few behavioral interventions integrate HIV-IPV prevention and are tailored for the unique developmental needs of adolescent boys. In this study, investigators build on previous scientific work that demonstrated the acceptability and feasibility of Safe South Africa, an integrated HIV-IPV intervention that uses a developmentally- and gender-tailored approach grounded in social norms theory to prevent adolescent HIV risk behavior and IPV. Investigators will conduct the work in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV in the world. The investigative team propose the following specific aims: (1) Tailoring Safe South Africa intervention content to address the unique behavioral and social norms data that drives HIV and IPV behaviors among boys in their socioecological environments. (2) Testing the efficacy of the Safe South Africa intervention in preventing HIV/STIs and reducing IPV frequency among N=836 adolescent boys (ages 15- 17), with the scientific team's working hypothesis that the intervention, relative to the usual care condition, will show (a) lower incidence of any STI (including HIV); and (b) reductions in IPV perpetration frequency and decreased endorsement of IPV supportive attitudes. (3) Identifying barriers and facilitators to implementing Safe South Africa within a school setting to provide data for future dissemination (presuming Safe South Africa is efficacious). Investigators will examine processes critical to future dissemination through (a) fidelity data examining adherence to core active components of the standardized intervention manual guiding consistent delivery of the intervention; and (b) qualitative data on the experience during and post-implementation from adolescents and stakeholders using N=20 in-depth interviews with each group.

Eligibility Criteria:
Inclusion Criteria:

* identification as boys
* ages 15-17 years
* enrolled at public high schools in South Africa situated in communities with high rates of HIV and violence

Exclusion Criteria:

* does not have written parental consent
* does not have written assent
A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men

This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study is divided into two parts, called the single ascending dose (SAD) part and multiple ascending dose (MAD) part, and each part will have more than one cohort (like sub-parts). No matter which part the participants will be enrolled in, they will either get the study medicine (Inno8) or a dummy medicine that looks like the study medicine but has no effect on the body (placebo). Which treatment participants get is decided by chance. The study medicine is a new medicine that cannot yet be prescribed by doctors. In the SAD part participants will receive a single injection of study medicine or placebo, and the study will last for up to 9 weeks. In the MAD part, participants will receive 1-2 tablets of study medicine or placebo daily for 10 days, and the study will last for up to 11 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-45 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive)
* Body weight between 60.0 and 100.0 Kilogram (kg) (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Factor VIII activity greater than or equal to (≥) 150% at screening
* Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis
* Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
* Any of the thrombophilia markers listed below:
* Protein C, protein S or antithrombin below the lower normal laboratory range
* Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening
Comparison of The Effects of Different Stretching Techniques in Overhead Athletes

78 overhead athletes with Glenohumeral Internal Rotation Deficit (GIRD) will be included in this study. Participants will be randomly divided into 3 different groups of 26 people. In each group will be applied posterior shoulder stretching exercises (PSSE) performed with different Muscle Energy Techniques (MET).

Post Isometric Relaxation Group (PIRG) participants will perform a PSSE with post isometric relaxation (PIR) technique, Isolytic Stretching Group (ISG) participants will perform a a PSSE with isolytic stretching technique and Static Stretching Group Group (SSG) participants will perform a PSSE with static stretching technique. All exercises will be performed in the modified crossbody position, for 5 times a week total of 6 weeks. Subacromial space, posterior capsule and muscle tendon thicknesses will be measured using a 7-12 MHz linear transducer with USG (LOGIQ e Ultrasound, GE Healthcare, USA). Athletes' GIRD results and rotational ROM measurements and Posterior shoulder tightness will be measured and recorded using a bubble inclinometer (Fabrication End Inc, New York, USA). Scapula kinematics (posterior tilt, upward rotation) will be evaluated with a digital inclinometer. Shoulder and scapular muscles will be evaluated with hend held dynamometer. Tightness of Levator scapulae and pectoralis minor will be assessed. The upper extremity functional performance of the athletes will be evaluated with the Functional Throwing Performance Index (FTPI). Evaluations will be performed before training program and repeated after 6 weeks of training, and at the 1st, 3th and 6th months after training program is completed and the effects of different muscle energy techniques (MET) will be compared. Investigators hypothesized 6 weeks of PSSE with different MET would have different effects on Acromio-Humeral Distance, posterior capsule thickness, muscle tendon thickness, rotational ROM measurements, scapula kinematics, muscle strength, posterior shoulder tightness and performance on overhead athletes with GIRD and the effects of MET would be superior to static stretching.

Eligibility Criteria:
Inclusion Criteria:

* Being overhead athlete
* Glenohumeral internal rotation range of motion of the affected shoulder should be less than other shoulder and bilateral shoulder internal rotation range of motion difference should be ≥15 º

Exclusion Criteria:

* Shoulder pain required medical attention for the last year.
* Current shoulder pain
* Cervical pain during upper extremity movement
* History of fracture to the shoulder girdle
* Systemic musculoskeletal disease
* History of shoulder surgery,
* Glenohumeral instability (positive apprehension, relocation, or positive sulcus test) or positive findings for a full thickness rotator cuff tear (positive lag sign, positive drop arm test, or marked weakness with shoulder external rotation)
Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with Oncogene Amplifications

BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies.

BBI-355 is administered orally in various dosing schedules to subjects with locally advanced or metastatic non-resectable solid tumors harboring oncogene amplifications, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.

Eligibility Criteria:
Key Inclusion Criteria:

* Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists,
* Single agent arm: Evidence of oncogene amplification,
* BBI-355 combination with erlotinib arm: Evidence of amplification of wildtype EGFR,
* BBI-355 combination with futibatinib arm: Evidence of amplification of wildtype FGFR1, FGFR2, FGFR3, or FGFR4,
* Availability of FFPE tumor tissue, archival or newly obtained,
* Measurable disease as defined by RECIST Version 1.1,
* Adequate hematologic function,
* Adequate hepatic and renal function,
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,
* Other inclusion criteria per study protocol.

Key Exclusion Criteria:

* Well-known tumor activating oncogene mutations or fusions,
* Prior exposure to CHK1 inhibitors,
* BBI-355 combination with erlotinib arm: Prior exposure to EGFR inhibitors,
* BBI-355 combination with futibatinib arm: Prior exposure to FGFR inhibitors,
* Hematologic malignancies,
* Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,
* Prior or concurrent malignancies, with exceptions per study protocol,
* History of HBV, HCV, or HIV infection,
* Clinically significant cardiac condition,
* Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,
* QTcF \> 470 msec,
* Prior organ allograft transplantations or allogeneic peripheral blood stem cell/bone marrow transplantation,
* Other exclusion criteria per study protocol.
Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study

This study will investigate the effect of caffeine and time of day on brain excitability using excitatory brain stimulation. The investigators will recruit a healthy participant and conduct a concurrent iTBS/fNIRS protocol for 20 consecutive sessions over four weeks with or without caffeine consumption before the stimulation. Moreover, the experiment will be conducted at different times of the day (morning or afternoon)

One healthy participant will be recruited for this study. The participants will be subjected to concurrent TBS/fNIRS, to which the iTBS will be applied on the left DLPFC and the NIRS will measure the prefrontal hemodynamic response simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed

Exclusion Criteria:

* history of epilepsy, seizures, or convulsions
* current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
* current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
* with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker
Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery

Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anaesthetic drug is run between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes


Eligibility Criteria:
* Inclusion criteria Adult patients between 18-60 years. Genders eligible for study: both sexes ASA physical status I and II Undergoing open nephrectomy surgery
* Exclusion criteria Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding disorders Use of any anti-coagulants Inability to provide informed consent ASA III-IV
Infant Simulator Training to Measure Pediatric Vital Signs

Providing training to nursing students in the field of pediatric care requires having the competencies to care for the pediatric population. However, as the margin of error in pediatric care is quite narrow, nursing students need to undertake a comprehensive laboratory practice before implementing their care skills unsupervised in the pediatric ward. Nursing students can develop their professional skills by gaining the necessary confidence and skills with simulation methods.

Simulation makes possible for students to feel a pulse, observe chest movements, hear respiration sounds, measure blood pressure, and evaluate results, thus allowing students to practice with concrete examples of various conditions. Hence simulation-based training, one of the important learning techniques, is assumed to help nursing students overcome the difficulties they will experience in measuring the children's vital signs

Eligibility Criteria:
Inclusion Criteria:

* Having taken the Pediatric Nursing course
* Voluntarily participating in the study

Criteria for exclusion from the study were as follows:

* Failure to complete the research process
* Filling out the necessary forms incompletely
The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Cultured EC and SMC

This research is NOT part of an interventional trial, however the investigators use umbilical cord after birth for isolating endothelial and smooth muscle cells for academic research.

Isolation and culturing of endothelial and smooth muscle muscles for academic research

Eligibility Criteria:
Inclusion Criteria:

* normal pregnancy

Exclusion Criteria:

-
68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas

This trial studies how well 68Ga-DOTATATE digital PET/CT work in diagnosing soft tissue sarcoma. 68Ga-DOTATATE is a radiotracer that may improve image quality of PET imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-DOTATATE. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. 68Ga-DOTATATE digital PET/CT may work better in imaging patients with soft tissue sarcomas.

PRIMARY OBJECTIVE:

I. To assess the feasibility and capability of gallium Ga 68-HA-DOTA-TATE (68Ga-DOTATATE) digital positron emission tomography (dPET)/ computed tomography (CT) imaging for soft tissue sarcomas.

SECONDARY OBJECTIVES:

I. To evaluate the clinical benefit of 68Ga-DOTATATE for a comprehensive assessment of soft tissue sarcomas (STS) using next-generation digital PET detector technology.

II. To describe the perfusion and early tumor uptake kinetics of tumor targets at baseline and following conventional systemic therapy using both 68Ga-DOT AT A TE dPET/CT and 18F-FDG dPET/CT approaches.

III. Using list-mode dPET acquisitions following standard 68Ga-DOTATATE dose administrations, imaging datasets will be retrospectively generated to simulate lower dose or faster image acquisition in order to define further the minimum 68Ga-DOTATATE dose and PET image acquisition times needed to maintain lesion detectability and PET quantification.

V. To assess the feasibility for 68Ga-DOTATATE dPET/CT to identify and stratify STS patients with SSTR2-positive soft tissue sarcoma lesions for future therapy planning using 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) for patients with 68Ga-DOTATATE-avid sarcomas.

VI. To assess the safety of 68Ga-DOTATATE in this patient population.

OUTLINE:

Patients receive gallium Ga 68-HA-DOTA-TATE intravenously (IV) and undergo dPET/CT over 60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and undergo dPET/CT over 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years of age
* Patients diagnosed with any stage of soft tissue sarcomas candidates for systemic therapies
* Patients with one standard of care PET/CT scan up to 30 days before enrollment at the Ohio State University facilities.

Exclusion Criteria:

* Hypersensitivity to somatostatin or similar peptides
* Somatostatin long-acting analog in the past 6 months
* Patients who are pregnant or lactating
* Patients who are currently incarcerated
* Patients with acute infections
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the dPET/CT scanner due to body mass index (BMI)