cyrilzakka/clinical-trials huggingface dataset:
SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma

This study is open to patients with primary HCC who cannot be treated by potentially curative treatment modalities, such as surgical resection, liver transplantation or percutaneous ablation.

Patients that satisfy the study eligibility criteria will be randomised in a 1: 1 ratio to receive either Radioembolisation with SIR-Spheres Microspheres or the standardised Transarterial Chemoembolisation procedure.

Study Objectives

This study will evaluate and compare quality of life as well as safety and efficacy of RE or TACE in patients with unresectable HCC. Patients will be followed for a minimum of 12 months or until death wherever possible in the evaluation of the primary and secondary objectives of this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged ≥ 18 years
* Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)
* Tumour characteristics as follows:

  * Not more than 5 lesions
  * If single, maximal diameter ≤ 10 cm
  * If multiple, sum of maximal diameters ≤ 15 cm
  * Lesions satellite to primary tumour of less than 1 cm in maximal diameter are not included
  * At least one quantifiable lesion on hepatic MRI
* Preserved liver function, corresponding to Child-Pugh class ≤ B-7
* ECOG performance status ≤ 2
* Life expectancy ≥ 12 weeks
* Female patients of childbearing potential must have a negative pregnancy test prior to inclusion in the trial and male and female patients must agree to use an effective contraceptive method for the duration of the trial.
* Willing and able to provide written informed consent

Exclusion Criteria:

* Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomisation.
* Ascites, which is detectable on physical examination or clinically symptomatic (but patients having ascites discovered by imaging only should not be excluded).
* Serum transaminases \> 5 x ULN
* Lung shunt \> 20%
* Extrahepatic disease
* Moderate to severe portal hypertension, as evidenced by any of the following criteria (occurring in spite of using common criteria for prophylactic treatment and therapy):

  * History of variceal haemorrhage in past 2 years
  * History of hepatic encephalopathy
  * Platelets \< 50.000 /ml
  * WBC \< 3.000 / ml
  * Previous TIPSS procedure
* Portal vein occlusion or hepatofugal flow.
* Impaired liver function

  * Total serum bilirubin \> 2.0 mg / dL
  * Serum albumin \< 3.0 g /dl
  * creatinine \> 2 mg / dL
* Chemotherapy or other experimental therapy within preceding 4 weeks
* Previous TAE / TACE
* Previous radiation therapy to liver or lungs
* Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis)
* Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE
* Any decompensated concomitant disease
* Female patients who are pregnant, breast-feeding, or pre-menopausal and not practising efficient contraceptive method (hormonal contraceptive, intra-uterine device)
Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
* Age in the 20 years or over inclusive
* HbA1c in the range of ≥ 6.5 to ≤ 10%

Exclusion Criteria:

* Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant heart diseases
* Significant diabetic complications
Emotional Skills Training with Social Robot

Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns.

In particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time.

Therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD).

The children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Language in sentences
* use of connectors
* ability to narrate events not present
* ADOS level: module 2
* Griffiths: QS\>75

Exclusion Criteria:

* presence of other medical disorders
Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease

The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function

Primary Purpose:

Other: The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function

Eligibility Criteria:
Inclusion Criteria:

* Group A: Subjects with normal renal function
* Group B: Patients with end stage renal disease
* Group C: Patients with mild renal impairment
* Group D: Patients with moderate renal impairment
* Group E: Patients with severe renal impairment

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
* Hepatitis B or C
* Human Immunodeficiency Virus (HIV)
* Recent gastrointestinal disease
Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery

The aim of this trial was to characterise the intra and post operative metabolic, endocrine and inflammatory response to laparoscopic fundoplication in children. We are testing the hypothesis that laparoscopic fundoplication is associated with a lack of hypermetabolism and catabolism and blunting of the endocrine/inflammatory stress response


Eligibility Criteria:
Inclusion Criteria:

* infants and children with gastro-oesophageal reflux

Exclusion Criteria:

* septic shock, multi-organ dysfunction syndrome, cardiac, renal or congenital metabolic abnormalities
ctDNA as a Biomarker for Treatment in Advanced NSCLC

The dynamic monitoring of circulating tumor DNA aims to evaluate the response and progression-free survival of short-course chemotherapy (2 cycles) combined with immunotherapy in patients with locally advanced unresectable or metastatic non-small cell lung cancer.

For patients with locally advanced unresectable or metastatic non-small cell lung cancers, 4-6 cycles of chemotherapy plus immunotherapy with immune maintenance therapy is currently the standard treatment. Short-course chemotherapy (2 cycles) combined with immunotherapy has been proved effective in some patients. Recently, circulating tumor DNA (ctDNA) has been detected in the cell-free component of peripheral blood samples in advanced non-small cell lung cancers and many other solid tumors. To identify the patients who can benefit from the short-course chemotherapy (2 cycles) combined with immunotherapy, dynamic monitoring of ctDNA in both 4-6 cycles and 2 cycles chemotherapy patients could be a promising alternative test.

Eligibility Criteria:
Inclusion Criteria:

* (1)Histologically confirmed non-small cell lung cancer; (2)Locally advanced unresectable or metastatic disease; (3)Male or female aged over 18 years and under 80 years; (4)Subjects must not have received any immunotherapy for advanced lung cancer, and have an estimated life expectancy of more than 12 weeks (5)Eastern Cooperative Oncology Group (ECOG) score as 0 \~ 1; (6)No EGFR mutation, ALK or ROS1 rearrangement; (7)Adequate tumor tissue for PD-L1 testing; (8)With at least one measurable lesion confirmed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)； (9)The subjects must sign the informed consent, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.

Exclusion Criteria:

* (1)Serious immune-related adverse events occurred; (2)Participation in other clinical study; (3)With the history of autoimmune disease or immunodeficiency disease; (4)History of another primary malignancy within 5 years; (5)Without complete clinical information; (6)Pregnant or lactating women; (7)Other conditions in which the investigator believes that the patient should not participate in this trial.
Ph1 Marinol Interaction Study - Part 1 - 1

The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.


Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 18 to 45 years of age
* Must be in good general health
* Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study
* Must be able to provide written informed consent
* Must be able to provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period
* If female and of child bearing potential, must agree to use birth control.

Exclusion

Criteria:

* Please contact site for more information.
Adenosylmethionine Metabolism in Human Inflammation

The investigators propose to conduct a translational study on the regulation of S-adenosylmethionine synthesis and cellular methylation reactions during chronic inflammation. Development of in vitro cell models may reveal the regulatory mechanisms by which specific inflammatory mediators cause metabolic changes and alter DNA methylation status. Metabolic and pharmacological studies in the in vivo models will enable us to better understand the regulation of inter-organ homeostasis of S-adenosyl methionine and help identify tissue specific biomarkers for methylation and epigenetic modifications in different stage of chronic inflammation. The clinical study in human subjects will help distinguish the impacts of autoimmune rheumatic disease, degenerated joint disease, or specific medication use on significant clinical and biochemical markers in folate and vitamin B6 metabolic pathways.The Investigators hope the present study can identify specific clinical markers for potential epigenetic changes in patients suffering from chronic inflammation, which will contribute to better clinical management of these diseases in humans.

The significance of epigenetic alterations in autoimmune rheumatic diseases and degenerated joint diseases has drawn great attention among clinicians and researchers. Aberrant methylation status has been demonstrated in human chronic inflammation yet more efforts have focused on global and sequence-specific hypomethylation and overexpression of specific genes. Few studies investigated the regulation of S-adenosylmethionine homeostasis and regulation during inflammation. At present the relevance and regulation of the complex epigenetic profiles and their modifications among different tissues and organs during inflammation remain largely unknown.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years

Exclusion Criteria:

* pregnancy,
* anemia (hemoglobin 10 mg/dL or lower),
* thrombocytopenia (platelet count below 50,000 cells/μL),
* abnormal serum hepatic transaminase (aspartate aminotransferase or alanine aminotransferase above 50 IU/L),
* diabetes or cancer
Effect of Epi-Off Technique Corneal CXL On Endothelial Count by Specular Microscopy in Keratoconus Patients

Determine safety of EPi-off CXL on corneal endothelium by using specular specular microscopy to assess endothelial count.

Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the size, shape and population of the endothelial cells. The instrument projects light onto the cornea and captures the image that is reflected from the optical interface between the corneal endothelium and the aqueous humor. The reflected image is analyzed by the instrument and displayed as a specular photomicrograph

Corneal collagen cross-linking (CXL) is a therapeutic procedure aiming at increasing the corneal stiffness in the keratoconus eyes by induction of cross-links within the extracellular matrix. It is achieved by ultraviolet-A (370 nm) irradiation of the cornea after saturation with the photosensitizer riboflavin. In the conventional CXL protocol, a minimum (manual) de-epithelialized corneal thickness of 400 μm is recommended to avoid potential irradiation damage to the corneal endothelium. In advanced keratoconus, however, stromal thickness is often lower than 400 μm, which limits the application of CXL in that category. Efforts have been undertaken to modify the conventional CXL procedure to be applicable in thin corneas. The current review discusses different techniques employed to achieve this end and their results. The overall safety and efficacy of the modified CXL protocols are good, as most of them managed to halt the progression of keratectasia without postoperative complications. However, the evidence of safety and efficacy in the use of modified CXL protocols is still limited to few studies with few patients involved. Controlled studies with long-term follow-up are required to confirm the safety and efficacy of it.

Eligibility Criteria:
Inclusion Criteria:

* Patients with corneal diseases that treated by collagen cross linking such as keratokonus and post lasic ectesia with corneal thickness above 400um at its thinnest location.

Exclusion Criteria:

1. Prior herpetic infection
2. Autoimmune disorders
3. corneal thickness below 400um at its thinnest location
4. Corneal opacity
Improving Brief Marijuana Interventions With a Behavioral Economic Supplement

The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and drug-related consequences in college student

Approximately 20% of college students are regular marijuana users, and are at risk for cognitive and academic problems, addiction, and risk behaviors such as driving while impaired. Young adult marijuana users are thus a high-risk population and may require an intervention that motivates marijuana reductions by increasing engagement in constructive alternatives to marijuana use. Brief Motivational Interventions (BMIS) have demonstrated efficacy for alcohol use in college students, but lack consistent evidence of efficacy for marijuana use. This research team has developed a supplement to alcohol BMIs, the Substance-Free Activity Session (SFAS), which directly targets the behavioral economic mechanisms of both substance-free reinforcement and delayed reward discounting by encouraging the development of and commitment to academic and career goals, and by highlighting the impact of day-to-day patterns of alcohol use and academic engagement on these goals. A controlled pilot trial found that the SFAS improved BMI outcomes in a sample of heavy drinking college students, and the ongoing parent trial to this revision is replicating and extending those results. This study will evaluate the SFAS using a randomized 3-group (BMI + SFAS vs. BMI + Relaxation Attention Control, vs. Assessment Only) pilot trial with 120 undergraduates (50% female, 40% minority) who report using marijuana on \> 5 days in the past-month. It is hypothesized that at the 1-month and the next-semester follow-ups (follow-ups are wedded to the academic calendar to allow for representative measurement of marijuana use and activity patterns) BMI+SFAS participants will report significantly lower levels of marijuana use and problems, and that these reductions will exceed those of BMI + Relaxation and Assessment-Only participants. Exploratory analyses will test the hypotheses that (a) the BMI + SFAS will be more effective for participants who report higher baseline marijuana reinforcing efficacy and delayed reward discounting; and (b) the advantage of BMI + SFAS on marijuana use will be mediated by increased participation in substance-free activities. Support for our hypotheses would extend behavioral economic theory and would provide initial validation for an approach that could be used to reduce marijuana misuse among the increasing population of college students who misuse marijuana. Furthermore, given the focus of the SFAS is to increase academic/campus engagement, this work has the potential for widespread dissemination.

Eligibility Criteria:
Inclusion Criteria:

* freshman or sophomore at the university of Memphis
* 5 or more past-month days of marijuana use

Exclusion Criteria:

-
Korea National Diabetes Program

This is an observational study done by creating a cohort of Korean patients with diabetes and those at high risk of developing diabetes. By the creation of this cohort we aim to establish efficient preventive, diagnostic, and therapeutic measures based on the characteristics of Korean patients with diabetes, and by doing so, we hope to ultimately decrease our country's diabetes-related-mortality and increase the quality of life of patients with type 2 diabetes.

It is estimated that in 20 years the number of patients with diabetes will be over 6 million. Therefore the importance of diagnosis, treatment, and prevention of diabetes needs no further emphasis. At the moment, current studies demonstrate that mortality has increased twofold in the last 10 years due to lack of adequate control, and that medical expenses related to diabetes is increasing. Therefore, the necessity to find means for effective prevention and management of diabetes seems pressing.

However, unfortunately, in Korea, results of systematic clinical trials carried out in the Korean population are not available. All the currently available management guidelines have been formulated based on the results of clinical trials carried out in other populations, on patients with perhaps different characteristics compared to ours. There are quite a number of problems in applying these guidelines to our patients.

This study's purpose is to create a basis on which we could establish effective prevention, diagnosis, and therapeutic plan based on specific characteristics of Korean patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

(Group 1:Diagnostic criteria for type 2 diabetes based on ADA 2004 guidelines)

* random plasma glucose \>200mg/dL + symptoms such as polyuria, polydipsia, unexplained weight loss
* fasting plasma glucose \>126 mg/dL or 75g oral glucose tolerance test (OGTT) 2h plasma glucose \>200 mg/dL (Group 2: High risk for diabetes based on ADA 2004 guidelines)
* IFG: fasting plasma glucose 100-125 mg/dL and 75g OGTT 2h plasma glucose \<140 mg/dL
* IGT: fasting plasma glucose \<100 mg/dL and 75g OGTT 2h plasma glucose 140-199 mg/dL (Group 3: Gestational Diabetes based on ADA 2004 guidelines)
* 50g OGTT 1h plasma glucose \>140 mg/dl
* 100g OGTT fasting plasma glucose \>95 mg/dl, 1h plasma glucose \>180 mg/dl, 2h plasma glucose \>155 mg/dL, 3h plasma glucose \>140 mg/dL

Exclusion Criteria:

-
Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)

The present longitudinal study aims to investigate the impact of lurasidone treatment in recent-onset psychosis patients. The effects of lurasidone will be studied primarily in terms of structural and myelin modifications, in relation to clinical outcomes, before and after treatment and in healthy controls. Furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.


Eligibility Criteria:
Inclusion Criteria for the experimental arm:

* Patients diagnosed with schizophrenia with onset in the past 5 years, diagnosed through a structured clinical interview (SCID-5 CV)
* Aged between 18 and 35 years
* Patients requiring treatment with lurasidone (independently from the inclusion in the present study) or that are being treated with lurasidone for 2 weeks maximum.
* no other psychotropic treatment during the 2 weeks preceding the beginning of the study
* Acceptance of the informed consent form for the participation to the study
* For women in childbearing age, negative pregnancy test (urine or blood Beta HCG) performed before the start of the treatment and use of a highly efficient contraceptive method (such as progestin contraceptives, estrogen-progestin contraceptives, IUD, IUS, bilateral fallopian tube blockage, vasectomized partner, sexual abstinence) throughout the duration of the treatment.

Exclusion Criteria for the experimental arm:

* presence of other psychiatric and/or neurological diagnoses
* previous antipsychotic treatment, except for patients that have been treated with other antipsychotics for less than a month and that have not been treated in the two weeks preceding the beginning of the trial, who are considered eligible.
* contraindications to lurasidone treatment (as per summary of product characteristics)
* intellectual disability
* alcool or substance abuse in the previous 6 months
* presence of absolute or relative contraindications to MRI
* underage patients
* no negative pregnancy test or no use of a highly efficient contraceptive method
* pregnancy (if a patient becomes pregnant during the course of the study, the subject will be excluded from the study)

Inclusion criteria for healthy controls:

* Aged between 18 and 35 years
* Acceptance of the informed consent form for the participation to the study

Exclusion criteria for healthy controls:

* presence of psychiatric and/or neurological disorders
* family history of psychiatric disorders in 1st-degree relatives
* intellectual disability
* other medical conditions at the time of the study
* family history of hereditary neurological diseases
* alcool or substance abuse
* presence of absolute or relative contraindications to MRI
* underage patients
* no negative pregnancy test or no use of a highly efficient contraceptive method
* pregnancy (if a subject becomes pregnant during the course of the study, the subject will be excluded from the study)
Evaluation of an Artificial Intelligence Algorithm Reducing Noise on Fast Whole-body Bone Tomoscintigraphy Acquisitions Recorded by a 360 Degree Cadmium-Zinc-Tellurid Camera

Recently, artificial intelligence algorithms reducing noise by deep learning have been developed with application to SPECT and PET images.

Many studies have reported the possibility of reducing the recording time in bone scintigraphy by applying artificial intelligence algorithms reducing noise

Only two studies compared images denoised by a Deep Learning algorithm to those denoised by conventional filters (Gaussian and median filters). The first study was conducted only on patients, without phantom analysis and without taking into account the size of the lesions. The second study included an analysis on phantom and patients, but with application to planar images rather than to SPECT images that are increasingly used today

The hypothesis of our study conducted on phantom and patients is that an artificial intelligence algorithm reducing noise could replace the conventional filters usually used in bone SPECT for the denoising of scintigraphic images.

Eligibility Criteria:
Inclusion Criteria:

Patients who had a whole-body thee dimensions bone scan for rheumatological or oncological indications.

Exclusion Criteria:

Patients opposed to the use of their data