cyrilzakka/clinical-trials huggingface dataset:
Low-contrast Dose Liver CT Using Lean Body Weight Low Monoenergetic Images and Deep Learning-based Reconstruction

This study aims to assess whether the acceptable image quality is achievable using low monoenergetic imaging of dual-energy CT with deep learning-based denoising, and low contrast media dose calculated based on lean body weight for the detection of hepatocellular carcinoma.

The use of iodinated contrast media in CT is associated with an immediate hypersensitivity reaction in a dose-dependent manner. Therefore, it is important to reduce the contrast dose for CT exams in patients who are required repeated CT examinations, including patients with hepatocellular carcinoma (HCC). Low monoenergetic images of dual-energy CT can provide higher iodine contrast than conventional images, thus enabling reduction of contrast media. The high image noise in low monoenergetic images may be improved by using model-based IR techniques and deep learning-based denoising (DLD) algorithms. Besides, lean body weight (LBW)-based contrast dose determination can be another option to reduce contrast media dose compared with total body weight-based dose determination since the volumes of blood and liver are not strictly proportional to total body weight. Therefore, we surmised that 50 keV images reconstructed with DLD algorithms with reducing iodine load by 30% based on LBW could produce the comparable image quality and lesion conspicuity compared with standard iodine-dose 120kVp images.

In this single-center prospective, randomized clinical trial, we aimed to investigate the effectiveness of low-contrast dose CT using 50 keV and DLD technique compared with the standard contrast-dose protocol using model-based IR in patients at high risk of HCC.

Eligibility Criteria:
Inclusion Criteria:

* High risk group for developing HCC
* Scheduled contrast-enhanced CT for HCC diagnosis or surveillance

Exclusion Criteria:

* not a high risk group for developing HCC
* body mass index is equal to or larger than 30 kg/m\^2
* suspected HCC \> 5cm in diameter
* received locoregional treatment or surgery for HCC within 3 months
* congestive hepatopathy
* no venous access on forearm
* anticipated beam hardening artifact due to prosthesis
* relative/absolute contraindication of contrast-enhanced CT
Comparison of N2O Inhalation and Ketamine in Pediatric PSA

* Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients
* However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies
* We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients

* There were 32 children who were randomly assigned
* Recovery times were markedly shorter in the N2O group compared with those in the ketamine group (median, 0.0 min (interquartile range \[IQR\], 0.0-4.0 min) vs. median, 21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p \< 0.05)
* Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales were comparable between groups
* No difference was observed in the satisfaction scores by physicians, parents, or nurses.
* N2O inhalation was preferable to injectable ketamine for pediatric patients because it is safe, allows for a faster recovery, maintains sufficient sedation time, and does not induce unnecessarily deep sedation

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with lacerated wound

Exclusion Criteria:

* Contraindication of ketamine or N2O gas
* A wound around eye and mouth
MRI Brain (Volumetry, fMRI & MRS) in Autism

To reach a feasible method for diagnosing Autism Spectrum Disorder (ASD) outcome measures:

1. Primary (main):

   Measurement of various brain structures, including the total brain volume, the volumes of specific brain regions (such as the amygdala, hippocampus, and cerebellum), and the thickness of the cortex.

   Detection of other concurrent lesions, e.g. tuberous sclerosis
2. Secondary (subsidiary):

levels of various neurotransmitters, such as glutamate and GABA, and other metabolites, such as N-acetyl aspartate (NAA), in specific regions of the brain Assessing neural activity and connectivity in the brain in the resting state

Autism spectrum disorder (ASD) is a heterogeneous disorder (or collection of related disorders) of multifactorial etiology, and with a great range in severity of symptoms. ASD affects approximately 1 in 166 children and is four times more prevalent in boys than in girls. Core features of individuals with autism include 1) impairment in reciprocal social interactions; 2) verbal and nonverbal communication deficits; 3) repetitive and ritualized behaviors; and 4) a narrow range of interests. Approximately 30% of individuals with ASD manifest some degree of mental retardation.

Magnetic-resonance (MR) examination allows researchers and clinicians to noninvasively examine brain anatomy in vivo. Structural MR examination is widely used to investigate brain morphology because of its high contrast sensitivity and spatial resolution, and because it entails no radiation exposure; the last feature is particularly important for children and adolescents.

Functional magnetic resonance imaging (fMRI) has proven to be a useful tool to investigate aberrant neurobiological function in ASDs because of its excellent contrast properties, spatial resolution, and temporal resolution. fMRI uses specialized pulse sequences to localize metabolic correlates of neural activity linked to relevant neurocognitive processes

Investigating brain network activity during the resting state has emerged as a new method that eliminates the caveats of task-based fMRI studies

The fMRI signal is measured during the resting state and the data is analyzed based on a connectivity approach between subdivisions. To date, brain network activity during the resting state has been investigated in subjects with ASD and typical development in numerous studies. Overall, intrinsic connectivity between subdivisions of the brain is altered in patients with ASD compared to controls.

MRS's finding is that gamma oscillations are reduced in ASD patients. Gamma oscillations are generated by GABAergic neurons and are involved in sensory binding and higher cognitive functions.

Eligibility Criteria:
Inclusion Criteria:

* Children clinically diagnosed with Autism Spectrum Disorder.
* Males and Females.
* Children with an IQ of more than 70%

Exclusion Criteria:

* Severe forms of ASD.
* Children with IQ less than 70%.
* Children with claustrophobia.
Effectiveness of Patient-Controlled Intravenous Analgesia (PCIA) With Fentanyl

To enhance post-operative pain management, patient-controlled intravenous analgesia (PCIA) has been employed. The fentanyl background PCIA therapy was created to solve the limitations of IV-based PCIA, such as programming errors, mobility limitations, and the risk of needle stick injuries. The goal of this trial was to observe how fentanyl patient-controlled intravenous analgesia pump (PCIA) and background infusion is worked in patients with post-total hip replacement analgesia.

Significant efforts to enhance the treatment of postoperative pain have resulted in the formulation and implementation of pain management guidelines, as well as the introduction of acute pain services in several hospitals during the last two decades.

Recent research, however, suggests that postoperative pain is still poorly controlled .

Hip replacement procedures are prevalent among the elderly, and they are significantly more painful .

The patient may suffer greatly as a result of the pain, which can also affect physiological functioning caused by hormonal changes caused by sympathetic nervous system activation .

Anaesthesiologists and patients alike are concerned about pain management following major surgery. It should also be mentioned that every pain management medication has certain side effects, especially when an opioid is utilized .

In the clinical ICU, patient-controlled intravenous analgesia (PCIA) has been used to improve postoperative pain management. Titrate analgesics according to demand. It typically provides better pain management and increases patient satisfaction when compared to "on-demand" opioid injections .

The settings programmed into the PCIA machine, such as the bolus dosage, lockout interval, dose restrictions, and background infusion, are included in the PCIA prescription. Each of these factors might have an impact on the safety and efficacy of PCIA.

A new fentanyl-based PCIA therapy has been developed to overcome constraints associated with PCIA provided by IV, such as programming mistakes, mobility limits, and the danger of needle stick injuries.

Prommer and colleagues demonstrated that a fentanyl dosage delivered through PCIA resulted in a mean C max of 1.954 ug/L and a mean absorption of 39.5 ug fentanyl per 10-minute dose delivery time .

Eligibility Criteria:
Inclusion Criteria:

- Patients with total fracture of Hip bones

Exclusion Criteria:

1. History of mental or neurological complaints,
2. Opioid and local anaesthetic allergies,
3. Opioid tolerance,
4. Smoking history,
5. local infection,
6. cemented total hip arthroplasty (THA), revision THA,
7. preoperative DVT,
8. renal failure,
9. bleeding tendency due to anticoagulant therapy
Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer

This is a Phase 1 open label dose ranging study to assess the safety and tolerability of oral RH324 in advanced non-small cell lung cancer

Eligibility Criteria:
Inclusion Criteria:

* Advanced Non-Small Cell Lung Cancer
* Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy
* Adults over 18 years
* Performance status (Eastern Cooperative Oncology Group) less than or equal to 2
* Life expectancy greater than 2 months
* Laboratory Values:

Hemoglobin greater than or equal to 9; neutrophils greater than 1,000; platelets greater than 50,000 Liver function tests less than or equal to twice upper limit of normal Serum Creatinine less than or equal to 2 Creatinine clearance greater than or equal to 30 mL per minute Hemoglobin A1C less than 7 Normal Thyroid function

* No history of hyperthyroidism
* Abstinence from alcohol and supplements
* Not pregnant, lactating and willing to use birth control throughout study
* Able to provide consent
* Positive Emission Tomography/Computer Tomography part of subjects care plan at baseline

Exclusion Criteria:

* Prior use of Withania somnifera
* Phenylketonuria
* Inability to swallow capsules
* Hypersensitivity to study drug ingredients
* Unstable medical or surgical condition
* History of additional cardiac risk factors
* Requiring drugs that are "strong" inhibitors of cytochrome P450
* Requiring irradiation
* Requiring intravenous fluids or hyperalimentation
* Requiring transfusions, dialysis, or other procedures
* Active infection
* Human Immunodeficiency Virus
* Must exceed washout period of prior treatments
* Psychiatric, neurological or other reason that precludes subjects ability to participate
Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)

Objective: This research agreement brings together French and Canadian teams of scientists, HIV testing centers and community based partners. The aim is to explore the feasibility and limitations of offering community based rapid HIV testing to men who have sex with men (MSM).

Background: Studies have shown that knowing one's own HIV positive status, may lead to a reduction in sexual risk behaviours. The introduction of new forms of rapid HIV testing in urban areas, may be of benefit to the public health sector, notably in identifying primary HIV infection, preventing secondary HIV transmission and decreasing the spread of HIV infection. Studies have also shown that rapid HIV testing, which yields same-day results, enables a greater number of individuals in populations at risk to become aware of their HIV status.

Issue: The working hypothesis is that the current screening system is not sufficiently suitable for MSM. A community-based rapid HIV testing program could better target the high risk MSM population and shorten the delay between risky behaviour and HIV testing.

Design: This intervention could enable the assessment of the feasibility of community-based rapid HIV testing. Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation or Centre de dépistage anonyme et gratuit in French) center testing with community-based rapid testing. A pre-study phase is first realised to characterize those in the MSM population undergoing HIV testing, before promoting and then beginning the survey. During the normal opening hours of five testing centers, clients will be randomized to have a rapid finger-stick blood specimen test or a conventional test. During evenings and week-ends (i.e. when the centers are closed) only community based rapid HIV testing will be proposed.

Schedule: The pre-study phase is planned for the first quarter of 2009. Promotion of the survey will begin one month before the experimental study which in turn will start in the third quarter of 2009 and will run for 7 months. The end of data analyses is planned for the end of 2010.

Outcome: We will compare HIV population exposure, screening history and the frequency of primary HIV infection diagnosis. We expect to find that those MSM who undergo community based HIV testing during evenings or week-ends, is a population who take repeated sexual risks and who have repeated HIV testing. We also expect to find that this form of testing will be characterized in terms of satisfaction as non-inferior compared to the classic one. In the long term, and if the results are confirmed, rapid HIV testing could be extended to strictly community-based sites.

Eligibility Criteria:
Inclusion Criteria:

* men who have sex with men
* Age ≥ 18 years
* Able to give written consent
* able to give written authorization for lifting anonymity if there is doubt of results
* Covered by French Social Security

Exclusion Criteria:

* who have had a previous diagnosis of seropositivity
* treated by antiretroviral
* woman
Effects of Magnetic Therapy and Seawater Combined in Decreasing Intraocular Presion.

Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular pressure (IOP) has been identified as the most important risk factor. However, some patients progress despite adequate IOP lowering while some subjects with elevated IOP never develop glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal range. Therefore, other factors must be involved. In the last years, studies using MRI have been performed and evidence has accumulated that also changes in retrobulbar structures are present, in particular in the lateral geniculate nucleus and the visual cortex. However, these studies were limited by the low spatial resolution of the MRI instruments used.

The two principal pathophysiological mechanisms of glaucomatous process (hydromechanical and metabolic) determine the development of two trends in the treatment of glaucoma. One treatment modality is aimed at reduction of intraocular pressure, the other at therapy of hemodynamic and metabolic disorders. General and local drug therapy and physiotherapy, including electro- and laser stimulation of the retina and optic nerve and magneto-therapy, are used to correct these disorders. Modern ocular hypotensive agents are myotics and beta-adrenoblockers, adrenergic drugs, alpha 2-agonists, carboanhydrase inhibitors, some prostaglandins, osmotic agents. The progress attained in conservative therapy of glaucoma should by no means be overstated. In many cases only a combination of conservative and surgical methods of treatment helps preserve vision in a glaucoma patient.

During the following investigation we will demonstrate that the use of Magneto therapy Ocular (MTO) reverses the symptomatology in Glaucoma patients. The use of Eyeglass magnetic prevents the development of Glaucoma disease.During the following investigation we will demonstrate that the use of MTO reverses the symptomatology of Glaucoma patients; the use of seawater as drops prevents the development of Glaucoma disease and the combined use of MTO and seawater is an effective therapy against Glaucoma disease that will cure a grand percentage of the patients.

We will randomized 100 glaucoma patients and will treat them with MTO (group 1) and seawater drop (group 2) and combined group 3 and will compare results

Eligibility Criteria:
Inclusion Criteria:

Patient is aged 18 years or older, with glaucoma include poorly controlled open angle glaucoma (Pigmentary \& Exfoliative Glaucoma) Patient is willing to participate in the 3-month study and to adhere to the follow-up schedule.

Patient is willing to review and sign a consent form.

Exclusion Criteria:

Prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.

Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.

Patient is pregnant. Patient might require other ocular surgery within the 6-month follow-up period. Having concurrent treatment with systemic steroids. Patient is under 18 years old -
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Non-amenable to curative hepatic resection as defined by FLR \<30%
* Histologically confirmed adenocarcinoma of the colon or rectum
* Candidate for LDLT for colorectal liver metastasis per the University of Rochester liver transplant program

Exclusion Criteria:

* Not a candidate of the LDLT liver transplant protocol for treatment of colorectal liver metastasis.
* Unwilling to consent
Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry

Commercially pure (CP) titanium is the gold standard to produce dental implants because it has a huge volume of scientific publications over a period of more than 50 years, it is cheap and simple to produce (i.e., making dental implants economically "affordable") and comes in numerous specitic designs of screws tor various indications. That is why more than 95% of the implant market 5 dominated by titanlum.

However, there is an innovation trend to manufacture implants from more inert and biocompatible materials. Ceramic implants represent a valuable alternative for expanding the patient base of clinicians, especially in cases with challenging aesthetic demand. Furthermore, there has been a significant increase in the number of patients requesting metal-free dentistry or bio-holistic implant treatments.

In the past, ceramics were often branded as "inferior" quality due to its reputation as being brittle but the growing volume of scientific publications specifically an zirconia are demonstrating that lt is comparable in fracture-strength with titanium implants. There is a clear market niche for zirconia implants, especially in cases of:

* Aesthetic reconstructions in the anterior region, especially in patients with a thin gingival biotype
* Gingival recessions where a white colored implant is a great advantage
* For patients with a titanium intolerance/sensitivity
* For patients who prefer a bio-holistic/metal-free dental approach.

Today, clinicians are asking tor long-term clinical results of zirconia as a dental implant material. Therefore, Z-Systems AG is conducting this zirconia dental implant registry. A registry design was chosen because it will capture long-term benefits/risks from clinical routine without patient selection.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the Z-Systems Z5m product group
* Patient has signed Informed Consent.

Exclusion Criteria:

• Inability to give consent
Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy

This is a phase IV pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. The main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.

Primary outcome is serum level of voriconazole on fifth day. Secondary outcome is a combined variable of therapeutic failure and adverse events, associated with voriconazole. A total of 146 patients with risk of undergoing invasive aspergillosis who potentially will receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient receives voriconazole finally, he will be randomized (1:1 experimental/control). In the experimental arm patients receive dose according to pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information. In the control arm patients receive dose according to clinical practice guidelines. In addition, a Spain national health system (NHS) point-of-view cost-effectiveness evaluation is going to be done. Direct costs calculation of each arm will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Patient at risk of developing invasive aspergillosis, that will potentially receive treatment or prophylaxis with voriconazole:

   A. Pediatric population: children who are going to receive a transplant of hematopoietic precursors (HSCT) and acute myeloid leukemias, as well as relapses of it.

   B. Adult population: patients diagnosed with acute leukemia, and those patients with expected prolonged neutropenia, secondary to hematological process and / or after specific treatment (aplastic anemia and variants, myelodysplastic syndrome, solid organ or bone marrow transplant, etc.), and those whose responsible clinician consider individually that they could present a risk of developing a fungal infection.
2. Those who agree to participate in the study by signing informed consent (patients equal or over 18 years old)
3. Subjects under 18 years old whose representative / legal guardian has voluntarily signed the informed consent.
4. In the case of mature under 18 years subjects (12-17 years of age), in addition to the consent signed by the legal guardian, the consent of the subject will be obtained.

Exclusion Criteria:

1. Patients who for any reason should not be included in the study according to the criteria of the research team.
2. Subjects who are not capable to understand the information sheet and unable to sign the informed consent.