cyrilzakka/clinical-trials huggingface dataset:
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants

Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development


Eligibility Criteria:
Inclusion Criteria:

* The participant was between ≥9 and \<18 years of age and weighs ≥20 kg.
* The participant was clinically indicated to undergo a transthoracic echocardiogram.
* The participant had a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized.
* The participant was able to comply with study procedures.
* A parent or legal guardian of the participant had signed and dated an informed consent form.
* Post-menarchal female participants must have had a negative urine pregnancy test at screening and at pre-dose on the day of OPTISON administration.
* Post-menarchal female participants must have been practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study

Exclusion Criteria:

* The participant was previously enrolled in this study.
* The participant received an investigational medicinal product within 30 days before or is scheduled to receive one from time of entry into this study until completion of the follow-up period proposed for this study.
* The participant had a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin.
* The participant had pulmonary hypertension or unstable cardiopulmonary conditions.
* The participant had severe liver disease based on medical history.
* The participant had a recent (\<6 months) neurological event.
* The participant presented any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the participant or other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study.
* The participant was a pregnant or lactating female, or was a female of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test was also required).
Sex-Informed Data in the COVID-19 Pandemic.

Sex and gender matter to health equity, especially in a pandemic. Sex (a biological attribute) and gender (a social construct) may influence an individual's susceptibility, vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARS and MERS), male sex was associated with worse outcomes. Both immune and the hemostatic response display ample sexual dimorphism.

The primary aim of the study is to determine whether sex differences in biomarkers of platelet and immune function, gut microbiome, clinical characteristics, therapy, clinical cost sensitive outcomes (i.e. in-hospital transition of care, case severity, and mortality due to COVID-19) exist in patients affected by COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients with laboratory confirmed SARS-Cov-2 infection of any severity.

Exclusion Criteria:

* Pregnancy.
* Younger than 18 years of age.
Impact of Home Exercise Delivery on Compliance & Outcomes for Musculoskeletal Pain

Patients seeking care for chronic low back or knee pain will be recruited for enrollment, and randomized within two phases (retention and compliance). Patients will consent to a 2-step study design, with independent randomization for each. The initial step will assess retention based on 4 different exercise prescription strategies. This will be assessed short-term, and then the 2nd step will consist of a second independent randomization to receive different reminder strategies to determine their influence on exercise compliance at home.

Patients seeking care for their chronic low back or knee pain will be recruited to participate in a trial investigating the value of different exercise and education prescription strategies as well as strategies to determine the influence of various exercise reminder strategies. On day 1 of enrollment, patients will be randomized and instructed in two different types and amounts of exercises, as well as two types of delivery strategies. The ability to recall and perform these exercises will be assessed 20 minutes after completion of the instructional period (retention). In phase 2, patients will be randomized to receive different reminder strategies (none, email, text, and/or video) and their compliance assessed over a 1 month period (compliance). Self-reported compliance over the first month, and health care utilization outcomes will be analyzed for the 1 year following completion of the 1 month period, in all groups.

Eligibility Criteria:
Inclusion Criteria:

1. The primary complaint of low back pain or knee pain and is not actively seeking care for their contralateral knee.
2. The current episode for the injury is 6 weeks or greater
3. A home exercise program is appropriate as part of the management plan for their injury on the first day
4. Between the age of 18 and 65 years.
5. Own and utilize a smart phone
6. Read and speak English well enough to interact with the smart phone-based tool.
7. Able and willing to come in for follow-up at 1-month.

Exclusion Criteria:

1. History of prior surgery to the lower extremities or spine
2. Already receiving or have received treatment for this episode of pain within the past 6 months.
3. Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, malignancy, joint infection, or systemic disease
4. If participating with low back pain, known current pregnancy or history of pregnancy in the last 6 months
5. Exiting military health system in the next 2 months, pending litigation, or pending a medical separation board.
HIV, Immune Activation and Salt Sensitive Hypertension

High dietary salt is associated with immune activation, elevated levels of inflammatory cytokines and hypertension in murine models. Hypertension is independently associated with inflammation in both murine studies and studies in humans. In people living with HIV, these interactions are not well established. The aim of this study is to determine the effect of excess dietary salt on immune cell activation, pro- and anti-inflammatory cytokines and blood pressure between individuals with and without hypertension among people living with HIV and HIV negative persons.


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18 and above) who will be required to verbally consent and sign a consent form
* HIV positive or HIV Normotensive individuals or hypertensive If HIV, on antiretroviral therapy ART treated hypertensive individuals

Exclusion Criteria:

* Existence of comorbidities such as diabetes mellitus and cancer Existing and recent past opportunistic infections, syphilis, hepatitis C and B virus infection and tuberculosis infection;
* Sick persons (clients seeking healthcare due to an illness rather than routine ART clinic reviews)
* Those with recent and current alcohol consumption and smoking status
Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry

The aim of the present registry is to prospectively collect data on patients treated with protontherapy in order to improve knowledge on indication, feasibility, and clinical results of hypofractionated schedules applied in the setting of patients.

Paucity and low evidence level data on protontherapy (PT) represent one of the main issues for the establishment of solid indications in the PT setting. Aim of the present registry is to provide a tool for systematic, prospective, harmonized, and multidimensional high-quality data collection to promote knowledge in the field of PT with a particular focus on the use of hypofractionation.

All patients with any type of oncologic disease (benign and malignant disease) who will be eligible for PT at the European Institute of Oncology (IEO), will be included in the present registry. Three levels of data collection will be implemented: Level 1 clinical research (patients outcome and toxicity, quality of life, and cost/effectiveness analysis); Level 2 radiological research (radiomic and dosiomic analysis, as well as biological modeling); Level 3 Biological and Translational research (biological biomarkers and genomic data analysis).

Endpoints and outcome measures of hypofractionation schedules will be evaluated in terms of either Treatment Efficacy (tumor response rate, time to progression/percentages of survivors/median survival, clinical, biological, and radiological biomarkers changes, identified as surrogate endpoints of cancer survival/response to treatment) and Toxicity.

The study protocol has been approved by the IEO ethical committee (IEO 1885). Other than patients treated at IEO, additional PT facilities (equipped with IBA Proteus®ONE or Proteus®PLUS technologies) are planned to join the registry data collection. Moreover, the registry will be also fully integrated into international PT data collection networks.

Eligibility Criteria:
Inclusion criteria:

* diagnosis of oncological disease (benign and malignant disease);
* candidates to proton therapy;
* able to provide informed consent.

Exclusion criteria:

- age \< 18 years.
Predictors of Cardiovascular Disease in the Elderly

To evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795 men and women aged 75 years or older at the time of a comprehensive examination conducted between 1984 and 1987.

BACKGROUND:

The study was needed because evidence in 1991 suggested that cardiovascular risk factors which had been identified by studies of middle-aged populations did not have the same predictive value in the elderly; especially the "oldest old" aged 75 and above.

DESIGN NARRATIVE:

The study analyzed data that had been collected over the years. At the time of the analysis, mortality follow-up was complete for over 99 percent of subjects, and incident morbidity information was available for myocardial infarction, coronary bypass surgery and stroke. The database included measurements which allowed: 1) prospective analyses of the effects of putative cardiovascular risk factors on disease incidence in the elderly, 2) prospective analyses of the impact of change in risk factors on events in the elderly, 3) exploration of risk factors not classically associated with cardiovascular events in younger populations but which may be important in the very old, and, 4) cross-sectional description of putative risk factors in an aged population.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars

This study aimed to evaluate the incidence of histopathologic changes in dental follicles associated with radiographically normal impacted lower third molar and to determine the relationship between cystic changes in follicle tissues and age, gender, and the angular position of the impacted tooth.

Patients One hundred one healthy patients whose ILTM were extracted for various reasons in Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery were included in the study. All participants included in the study signed an informed consent form. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by Tokat Gaziosmanpaşa University Clinical Research Ethics Committee for the study (Project number: 19-KAEK-081).

The patients' panoramic radiographs were examined, and the impacted teeth were divided into four groups as vertical, horizontal, mesioangular, and distoangular according to their angular positions. The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study. The follicular tissues were also excised after tooth extraction. Soft tissue samples taken during surgical removal of ILTM were evaluated in the department of pathology.

Histopathological evaluation The excision materials obtained for the study were subjected to routine tissue follow-up procedures in Tokat Gaziosmanpaşa University, Faculty of Medicine, Pathology Department. The samples were fixed in 10% formalin solution for 24 hours for light microscope examination and blocked using the routine paraffin blocking method. The preparations were prepared by obtaining sections with microtome from the blocks. These preparations were stained with Hematoxylin Eosin and evaluated under a light microscope. In the histopathological examination, squamous epithelium, keratinization, odontogenic epithelial residue, and fibrosis were evaluated as either present or absent, and inflammation was scored as 0-absent, 1-mild, 2-moderate, or 3-severe. During the microscopic evaluation of follicular tissues, soft tissue samples with stratified squamous epithelium were identified as cystic.

The relationship between histopathological changes observed in the radiographically normal dental follicles and gender and the teeth' angular positions was statistically evaluated.

Eligibility Criteria:
Inclusion Criteria:

The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study

Exclusion Criteria:

individuals with systemic disease
Exacerbation Risk in Asthma

The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.


Eligibility Criteria:
Inclusion Criteria:

* Patients with least two asthma diagnosis
* Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
* Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use

Exclusion Criteria:

* Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
* Patients less than 12 years of age
* Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
* Patients with prior Tio or ICS/LABA use during the 6-month baseline period
* Patients with urinary bladder obstruction, urinary retention, and glaucoma
* After the propensity score matching (PSM) process, unmatched patients
Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity

The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.

This was a worldwide observational registry of the use of the EndoBarrier for inclusion of subjects treated with the EndoBarrier in centers in Australia, Chile, and the Netherlands. The registry was open to all subjects at participating centers that received the EndoBarrier.

Eligibility Criteria:
Inclusion Criteria:

* As per IFU, the EndoBarrier GI liner System is used for the treatment of obese type 2 diabetes with BMI greater than or equal to 30 kg/m2, or obese patients with BMI greater than or equal to 30 kg/m2 with less than or equal to 1 co-morbidities, or obese patients with BMI greater than 35 kg/m2. The GI liner is indicated for a maximum implant duration of 12 months.

Exclusion Criteria:

As per Instructions For Use (IFU)

* Women who are pregnant
* Requirement for prescription anticoagulation therapy
* History of inflammatory bowel disease or condition of the gastrointestinal tract, such as peptic ulcer disease (PUD), ulcers, or Crohn's disease
* Pancreatitis, Uncontrolled gastroesophageal reflux disease (GERD), Known infection at the time of implant
* Symptomatic coronary artery disease or pulmonary dysfunction
* History of coagulopathy
* Bleeding diathesis, upper GI bleeding conditions such as esophageal or gastric varices, or congenital or acquired intestinal telangiectasia
* Congenital or acquired anomalies of the GI tract such as atresias or stenosis
* Previous GI surgery that could affect the ability to place the EndoBarrier Gastrointestinal Liner or its function
* Iron deficiency and/or iron deficiency anemia
* Active symptoms of kidney stones or known presence of gallstones
* Inability to discontinue use of non-steroidal anti-inflammatory drugs during the implant period
* Family or patient history of known diagnosis or pre-existing condition of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder
* H. pylori positive status (Patients may receive the EndoBarrier Gastrointestinal Liner if they had a prior history and were successfully treated)
Ossiview Normative Mobility Data Collection Protocol

The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. The targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss.

The main questions the study aims to answer are:

* What are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus?
* Are there any significant differences in these vibrational responses associated with sex or age?

Participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. Standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants.


Eligibility Criteria:
Inclusion Criteria:

* Normal-hearing
* Over the age of 18
* At least one of incus or umbo visible under otoscopic examination
* Type A 226Hz tympanogram with peak static compliance occurring at pressure between -99mmH20 and +50mmH20 and peak static compliance in the range from 0.3 to 1.6 cc

Exclusion Criteria:

* Audiometric air conduction thresholds greater than 40 dBHL at 500 Hz, 750 Hz, 1000 Hz, 1500Hz, 2000 Hz, 3000 Hz
* Audiometric air bone gap greater than 5dB at 500Hz, 750Hz, 1000Hz, 1500Hz, 2000Hz and 3000Hz
* Self-reported history of ear infection in the previous 3 months
* Self-reported history of middle ear surgery in the last 5 years
* Self-reported history of tympanic membrane perforation within the last 5 years
* Self-reported medical treatment for any ear-related disorder within the last 5 years
* Evidence of perforation, tympanosclerosis, otitis externa, thickened or fibrotic eardrum, mycosis, fluid, infection or other ear abnormality under otoscopy
MRI Findings of Encephalopathy Associated With Carbon Dioxide (CO2) Intoxication

Carbon dioxide intoxication is a rare condition and only few case reports are found in the literature. There were six patients who suffered from carbon dioxide intoxication in our hospital about two years ago. Two of them are more severe with conscious change and brain MRI studies of the two patients were performed. Reviewing the literature, no any report has mentioned about the encephalopathy associated with carbon dioxide intoxication. We want to review the brain lesions on the diffusion weighted images and the laboratory data of the patients for further diagnostic help.


Eligibility Criteria:
Inclusion Criteria:

* CO2 intoxication

Exclusion Criteria:

* None CO2 intoxication
Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes.

Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. Nanoparticles are injected close to the rectal cancer and migrate to adjacent lymph nodes.The time-varying magnetic field will influence the nano particles in the lymph node enhancing diagnosis of affected lymph nodes. The aim is to improve diagnosis of mesolectal lymph nodes and compare the results of magnetomotoric ultrasound with MRI and final histopathology.

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer
* Scheduled for total mesorectal surgery
* Informed consent

Exclusion Criteria:

* Not able to give informed consent
* Synchronus colorectal cancer
Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear

RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia.

PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia in patients with an abnormal Pap smear.

OBJECTIVES:

* To identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC), a device that uses fluorescence and reflectance spectroscopy to compare images with histopathologic mapping of the cervical epithelium.
* To measure MDC images in vivo of the cervix using a modified device that makes measurements in seconds rather than over 2 minutes before and after acetic acid.
* To evaluate, preliminarily, the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the grade of intraepithelial neoplasia.
* To evaluate mapping of the cervix so that software can reconstruct the cervical epithelial map to compare the map with routine colposcopic images as well as with those from the MDC.
* To compare, preliminarily, MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP).

OUTLINE: This is a multicenter study.

Patients undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take images of the vagina and cervix, pre- and post-acetic acid, using white, green, and blue light. Colposcopically abnormal areas are biopsied; a normal area may also be biopsied. Patients undergoing loop electrosurgical excision procedure (LEEP) may undergo one additional biopsy of a colposcopically normal site.

Eligibility Criteria:
Criteria

Inclusion criteria:

* Included subjects will be ≥18 years old.
* Included subjects will not be pregnant.
* Included subjects will have a negative urine pregnancy test.
* Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
* Included subjects will indicate understanding of the study.
* Included subjects will provide informed consent to participate.

Exclusion criteria:

* Individuals \<18 years old will be excluded.
* Pregnant individuals will be excluded.
* Individuals that have had an operation to remove their cervix will be excluded.