cyrilzakka/clinical-trials huggingface dataset:
Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements

The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the Smith \& Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for the Smith \& Nephew BCS TKA and compared these kinematics data to those of normal knees.

The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Journey II PCR or BCR TKA and compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith \& Nephew Journey II BCS TKA.

Eligibility Criteria:
Inclusion Criteria:

* Must have must either a Smith \& Nephew Journey II PCR or BCR TKA
* Must be at least three months post-operative
* Must have a Knee Society score of \>90 with no ligamentous laxity or pain
* Weigh 250 pounds or less
* Should have good-to-excellent post-operative flexion
* Must be able to perform activities (without aid of any kind) and without pain, walking up and down a ramp, performing a deep knee bend and rising from that kneeling position after the deep knee bend
* Must not have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
* Must have body mass index (BMI) of less than 38
* Must be between 40-85 years of age
* Must be willing to sign the Informed Consent (IC) / HIPAA and PHI Release forms to participate in the study

Exclusion Criteria:

* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study
* Subjects without the required types of knee implants
* Subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain
* Subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
Oleocanthal Rich Olive Oil Acute Effects on Hyperglycemia and Platelet Activation in T2DM

This is a pilot acute dietary intervention study with a randomized cross-over design aiming to investigate whether acute supplementation of extra virgin olive oil (EVOO) rich in oleocanthal could attenuate postprandial hyperglycemia and activation of platelets in T2DM patients. For this reason, non-insulin dependent diabetic patients (10-15) will be randomly assigned to consume in five different days white bread (50 g CHO) with butter, butter with ibuprofen, refined olive oil and olive oil with oleocanthal (250 mg/Kg 500 mg/Kg). Blood samples will be collected pre- and post-intervention up to 4 hours in order to determine platelet aggregation, postprnadial glycemia, lipemia, inflammation and oxidative stress.

Taking into account the strong anti-inflammatory and anti-platelet properties of oleocanthal, this study will assess whether oleocanthal-rich olive oils could exert similar effects under real in vivo conditions in T2DM patients. It will also assess whether these effects are achieved through improvement of postprandial glycemia and lipemia.


Eligibility Criteria:
Inclusion Criteria:

* adult patients diagnosed with T2DM
* stable weight the last two months
* smokers or not
* no restriction regarding the menopause

Exclusion Criteria:

* insulin therapy
* antiplatelet, anti-coagulant, anti-inflammatory and anti-depressant medication
* chronic inflammatory disease
* autoimmune diseases
* cancer
* uncontrolled thyroid disease.
* supplement consumption the last two months
Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

The aim of our study was to use Electrical Cardiometry EC to monitor hemodynamic alternations during pharmacological closure of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates

PDA in the first three days of life is a normal physiologic remnant in healthy term neonates. Conversely, a PDA in preterm neonates causes significant clinical sequelae as a result from left to right shunting. It is widely recognized that a hemodynamically significant PDA is known to contribute to increased morbidity and mortality. The increase in pulmonary blood flow in the setting of prematurity leads to pulmonary edema, noncompliant lungs, and worsening of respiratory status. Other sequelae of a hemodynamically significant PDA include intraventricular hemorrhage, necrotizing enterocolitis, congestive heart failure, and failure to thrive.

Echocardiography is often used to evaluate hemodynamic significance of PDA. In general, pharmacological closure of PDA is less successful in infants with ductal diameter \&gt;2mm. Lower ductal maximum velocity, which is usually associated with a larger PDA or higher pulmonary pressure, is another predictor of treatment failure .

The use of echocardiography to gather meaningful hemodynamic data often necessitates serial assessments that can be tedious and labor-intensive. Electrical cardiometry (EC) is a non-invasive, impedance-based monitor that provides absolute cardiac output estimates in clinical practice. Unlike echocardiography, EC is simple to apply, continuous in measurements and not operator dependent.

Eligibility Criteria:
Inclusion Criteria:

* All preterm newborns who were admitted throughout the duration of the research.

Exclusion Criteria:

* Newborn with congenital heart diseases.
* Newborn with acquired heart diseases (viral myocarditis)
* Newborn with dysrhythmias
* Newborn with symptomatic cardiac dysfunction secondary to extra cardiac diseases
* Newborn with significant pulmonary hypertension or systemic hypertension
The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA

To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.

To assess safety and efficacy of a technique for temporary aneurysm sac re-perfusion (TASreP) after total endovascular exclusion of TAAA, using a guide-wire left into the aneurysm sac. The technique can be applied both in elective that urgent cases.

The guide-wire aim to be a "safe-line" for fast temporary trans-sealing aneurysm sac re-perfusion in case of SCI occurring in the early post-operative period (48-to 72h).

Before completing exclusion, from the percutaneous femoral access, a second buddy-wire (V-18 guidewire; Boston Scientific) is advanced and left posterior to the endograft into the aneurysmal sac; through the main guide-wire, the final aneurysm exclusion is completed with distal stent-graft deployment and the femoral access sealed with Proglide leaving in place the sole V.018 draped in a sterile fashion. In the case of SCI occurrence in the post-operative period up to 48-72 hrs, the trans-sealing V.18 "safe-line" can be rapidly exchanged with a 6F/65 cm long Destination cm guiding sheath (Terumo) and positioned into the aneurysmal sac; this can be connected to a 6F introducer from the contralateral femoral artery and the sac perfused in a retrograde fashion.

Eligibility Criteria:
Inclusion Criteria:

* Thoraco-abdominal aortic aneurysm including type I,II,III,IV and V.
* Pararenale aneurysm
* Thoracoabdominal aortic aneurysm Elective and Urgent, endovascular repair;
* Endovascular repair of any thoracoabdominal aortic condition

Exclusion Criteria:

-thoraco-abdominal aortic aneurysm open repair
Assessment of Eloquent Function in Brain Tumor Patients

Purpose of the study:

AIM 1: Prospectively collect pre-operative \[functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)\] and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.

AIM 2: Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above.

Any patient with a primary or metastatic brain tumor in or near an eloquent area would be eligible for participation in the study assuming no contraindications to any of the studies or operative procedure.

Pre-operative evaluation will include clinical evaluation, neuropsychological testing, magnetic resonance imaging (MRI) brain with and without contrast, fMRI, DTI tractograms, and MEG studies as well as standard pre-operative work-up.

Intra-operative procedures include all non-invasive pre-operative mapping data being incorporated into the operative procedure with imaging tools that are routinely used during neurosurgical procedures. Participants will have awake mapping performed. Usual standards of care will be followed during craniotomy, mapping, and tumor resection or biopsy.

Post-operative procedures include routine post-operative care and assessment consisting of clinical examinations and imaging obtained within 24 hours post-resection. Participants will have routine follow-up outpatient appointments after surgery which will include neurologic assessment and follow-up imaging (MRI with and without contrast) for their tumors as appropriate. The experimental portion of the protocol is incorporating repeat neuropsychological testing and mapping studies (fMRI, DTI, MEG) studies at 2 and 6 months post-surgery into their routine follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 19 years and older
* Brain tumor in or near eloquent brain regions that is appropriate for attempted resection
* Appropriate body habitus and mental status/capacity to participate with non-invasive or invasive mapping
* Benign or malignant intra-axial brain tumor
* Primary or metastatic intra-axial brain tumor

Exclusion Criteria:

* Any contraindication to MRI (i.e. implanted devices)
* Inappropriate body habitus or mental status/capacity to participate with non-invasive or invasive mapping in a safe and reliable manner
* Declining to participate
* Lacks capacity to understand the study or consent for themselves
* Neurologic status which precludes testing (poor function- not testable)
* Positive pregnancy test
* End stage renal disease or severe renal dysfunction
Application of Smart Devices in Adolescent Weight Control

According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. WHO consider Health Literacy is the cognitive and social skills which determine the motivation and ability of individuals to gain access, to understand and use information.

The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.

According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. WHO consider Health Literacy is the cognitive and social skills which determine the motivation and ability of individuals to gain access, to understand and use information.

The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.

According to the purpose, the study will be multi wave longitudinal panel study. The study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent.

There are two blocks in the mobile phone applications: questionnaire block and Weight status block will be design for the study. Questionnaire block include demography, and health literacy scales and diet diary. Weight status block include height, weight, waist circumference, and hip circumference. After the participant key-in the height and weight, the system will automatically calculate the BMI, also show the results of the BMI. The standard for BMI interpretation was by Dr. Chang's research about New Growth Charts for Taiwanese Adolescents.

The data of smart watches will be upload into the NTUH health cloud system (named NTU MED GOD). This is the NTUH health cloud, different kinds of medical materials and data could be sent to the system, such as mobile phone and smart watches data.

Eligibility Criteria:
Inclusion Criteria:

* 13-19 years old adolescents;
* Could use their mobile phones to upload diet records and fill out the questionnaire;
* Adolescents and their parents agree to involve in the study and sign the consent form.

Exclusion Criteria:

* Severe diseases;
* Participate in other weight control program.
Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis

The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 12 or older
* Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study
* Signed informed consent

Exclusion Criteria:

* Age \< 12 years
Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?

The primary objective of this study is to prospectively assess in randomized fashion whether short term anti-seizure prophylaxis in traumatic brain injured patients decreases the incidence of seizures in the early post-injury period. A secondary objective is to evaluate whether there are differences in mortality, hospital length of stay, functional outcome at hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for patients who receive and do not receive anti-seizure prophylaxis.

The efficacy of anti-seizure prophylaxis in head injury patients remains controversial. Current recommendations for the use of anti-seizure prophylaxis are based upon a single institution study that has not been reproduced with other studies contradicting their conclusions. The proposed study will be a randomized prospective study at Loyola University Medical Center to assess the efficacy of anti-seizure prophylaxis in patients who have suffered traumatic brain injury (TBI). Patients with suspected TBI will undergo computed tomographic (CT) scan of the head. Following identification of TBI on CT scan, patients will be randomized to one of two study groups. Patients will be randomized to receive a seven-day course of anti-seizure prophylaxis with levetiracetam (UCB Pharma Inc.; Keppra) or randomized to a study group that will not receive anti-seizure prophylaxis. Patients will be consented prior to entry in the study. Patients will be followed for a total of seven days post injury for clinical signs of seizure activity. Additionally, patients will be assessed at one month post injury for clinical signs of seizure activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have suffered intracranial injury identified by CT Scan

Exclusion Criteria:

* Age less than 18
* Pregnant patients
* Death in ED
* Seizure history or use of antiepileptic medication prior to admission
* Contraindication to study drug
* Any post-injury seizures prior to randomization
Study of Patients With Thrombotic Microangiopathy Associated With Mitomycin C, Treated or Not With Eculizumab

Thrombotic microangiopathies (TMA) are defined as a triad combining mechanical hemolytic anemia, peripheral thrombocytopenia and ischemic organ damage.

Mitomycin C is an alkylating agent used as chemotherapy in adenocarcinomas of the breast, lung, pancreas, rectum and anal carcinoma. Mitomycin-C-induced TMA (m-TMA) is a potentially serious complication of chemotherapy: its estimated incidence ranges from 4 to 15% and its mortality exceeds 70%, with an estimated median survival of 2 months. This can also be responsible for kidney failure, sometimes requiring hemodialysis. The time to onset of m-TMA varies from one week to 15 months after the last infusion and is believed to depend on the cumulative dose of mitomycin C.

Eculizumab is a monoclonal antibody that binds to complement protein C5, blocking activation of the terminal complement pathway and formation of the membrane attack complex. This therapy has significantly changed the prognosis of patients with atypical hemolytic uremic syndrome (HUS), a disease in which complement activation plays a central role in TMA. Recently, a retrospective study suggested efficacy of eculizumab in TMA induced by gemcitabine, another chemotherapy, with normalization of platelets and LDH in 83% of patients, and partial or complete renal recovery in 67% and 17% of patients. These results provided arguments in favor of a potential benefit of complement-targeted therapies in TMA induced by certain chemotherapies. However, data on eculizumab in m-TMA remain extremely limited to date.

The objective of this study is to describe the clinical, biological and histological presentation of patients with m-TMA and their evolution after treatment with or without eculizumab.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>=18 years)
* Having received treatment with mitomycin C (regardless of the method of administration and indication) between 01/01/1990 and 12/31/2023
* and having developed a picture of thrombotic microangiopathy attributed to mitomycin C:

  * biological: defined as: thrombocytopenia \<150G/L and mechanical hemolytic anemia (at least 3 out of 4 criteria: hemoglobin \< 12g/dL, presence of schistocytes in blood smear, LDH \> 1N, collapsed haptoglobin (\< lower limit of the limit of laboratory normal)
  * or renal: pathological diagnosis of thrombotic microangiopathy on renal biopsy
* having received or not treatment for the episode of microangiopathy, including or not complement inhibitors (Eculizumab).
* Subject not opposing, after information, the reuse of their data for the purposes of this research

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Test for positive Shiga toxin
* ADAMST13 activity \<10%
* Thrombotic microangiopathy attributed to metastatic cancer (infiltration of bone marrow or circulating erythroblasts)
* Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
* Subject under judicial protection
* Subject under guardianship or curatorship
Convolutional Neural Network in Ovarian Follicle Identification

A prospective cohort trial studying patients with infertility undergoing an ovarian stimulation with exogenous gonadotropins. Ovarian monitoring will be performed with a combination of transvaginal ultrasound and 2 dimensional human measurements of the follicle development on the right and left ovaries along with SonoAVC. Human and SonoAVC measurements will then be compared to mask region-based convolutional neural network in follicle identification and measurement during during the ovarian stimulation.

This is a prospective cohort trial in which a total of 80 female subjects with infertility between the ages of 21 and 42 years of age undergoing ovarian stimulation will be recruited. After giving informed written consent the subject to undergo standard ovarian ultrasound monitoring with transvaginal ultrasounds during the ovarian stimulation. Monitoring will be performed with two-dimensional measurements of each follicle greater than 10 mm in size by the ultrasonographer. SonoAVC will then be applied to both ovaries for automated counting and measurement of the follicles within the ovaries. The patient will then undergo two 6-second ultrasounds of the right and left ovaries which will then be transmitted in a DICOM format to mask regional based recurrent neural network which is been trained and validated for follicle detection and quantification using curated transvaginal ultrasound images.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women ages 21-42 years old undergoing ovarian hyperstimulation as part of the treatment care.

Women with at least one ovary visible with transvaginal ultrasound. Women with at least one follicle 10 mm or greater in average diameter.

Exclusion Criteria:

* Women less than 21 years of age or greater than 42 years of age. Women without a visible ovary by transvaginal ultrasound. Women without a follicle at least 10 mm in average diameter
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Children, 4 months to 16 years of age
* Patient has received a kidney transplant
* At risk of developing cytomegalovirus disease
* Adequate hematological and renal function
* Able to tolerate oral medication
* Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

* Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
* Severe uncontrolled diarrhea (more than 5 watery stools per day)
* Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase \[AST (SGOT)\] or alanine aminotransferase \[ALT (SGPT)\]
* Patient requires use of any protocol prohibited concomitant medication
* Previous participation in this clinical study