cyrilzakka/clinical-trials huggingface dataset:
Role of MRI in Detection of Minimal Hepatic Encephalopathy

Introduction Liver cirrhosis (LC) is irreversible fibrosis of the liver (1) and it remains a public health problem. One of the complications of the cirrhosis is hepatic encephalopathy (HE) which is defined as brain dysfunction caused by liver insufficiency. Pathophysiological mechanisms of HE are complex and multifactorial. Recognition of beginning stages of HE, such as minimal HE (mHE) is of most importance.

Objectives and originality of the project Diagnosis of mHE can be challenging, time-consuming and, at least to some extent, subjective. This project will assess the role of magnetic resonance (MR) in mHE diagnosis with emphasis on multimodal imaging technique. With advanced magnetic resonance (MR) techniques, in-vivo detection of intracellular water content, estimation pH and metabolites levels with millimolar concentrations can be easily performed. This will offer to explore possible pathophysiological mechanisms of HE and to evaluate the results from previous, studies that were mainly performed on animal models or cell cultures.

By our best knowledge, multimodal MR approach as the investigators propose in this application has not been yet performed. The investigators will use advanced MR techniques which are currently not available in the clinical setting and require multicenter collaboration.

Methods The investigators will include 10-20 patients of both genders with hyperammonemia and mHE and 10-20 patients of both genders with HE. Diagnosis of HE will be made based on results of validated neuropsychiatric test. Age-matched and gender-matched control group with no gastrointestinal, neurological or psychiatric complaints and normal levels of ammonia in the blood. Patients with mHE/HE will be included from outpatient clinic of the Department of gastroenterology, University Medical Centre (UMC) Ljubljana. Healthy controls (HC) will be invited to join via internet advertisement. Contraindications for HC will include gastrointestinal (emphasis on liver disease), neurological or psychiatric complaints. Grade of mHE/HE will be classified according to West-Haven (WH) classification. Patients with different degree of liver cirrhosis, which will be scored with the Child-Pugh (CP) score, and with no contraindications for MR (e.g. presence of metal in body) will be included. Blood levels of liver enzymes and ammonia will be measured in all participants. MR scanning will include: T1- and T2-weighted MR, MRS (MEGA-PRESS and PRESS) in two voxels: striatum and cerebellum. Location will be double-checked by voxel position screenshots. Analysis, with voxel-positioning error compensation will be performed in Gannet (www.gabamrs.com). Moreover, high resolution diffusion weighted imaging (DWI), diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM) will be performed in brain as well. Liver QSM will be executed to assess iron load.


Eligibility Criteria:
Inclusion Criteria:

* Known liver disease/cirrhosis

Exclusion Criteria:

* Pregnancy, non compatible material with MRI
Evaluation of a Patient-Reported Symptom Index for NMIBC

This project will develop and evaluate a patient-reported symptom index to assess the impact of treatment for non-muscle invasive bladder cancer on patient burden, toxicity, symptoms and side effects. The symptom index will provide a method for assessing treatments from the patient's perspective; help healthcare professionals make better informed treatment decisions, and provide a method to be able to effectively evaluate treatments for non-muscle invasive bladder cancer.

The overarching aim of this research is to develop and evaluate a patient-reported Symptom Index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients, reliable, valid and responsive, and fit for purpose in clinical trials and clinical practice.

Specific clinical aims:

* Assess and compare key Patient-Reported Outcomes (PROs) across the full range of contemporary treatments for NMIBC, and over the disease trajectory including acute treatment and 1year survivorship;
* Compare PROs between patients with low, intermediate, and high risk NMIBC.

In field test 1, 200 participants will complete one questionnaire either in hard copy (pencil and paper) or online, at a time that is convenient for the participant. The questionnaire may take up to 20 minutes to complete.

In field test 2, 250 participants will complete quality of life questionnaires at four different time points; 1) before tumour resection, 2) 1 week after resection, 3) 8 weeks after resection, and 4) 1 year after resection. The questionnaires can be completed in the clinic or at home, either in hard copy (pencil and paper) or online, at a time that is convenient for the participant but still within the relevant time point. The questionnaires may take up to 30 minutes to complete.

Eligibility Criteria:
Field test 1:

Inclusion Criteria:

* diagnosed NMIBC
* Adult (\>18yrs)
* able to read and understand English
* undergoing active treatment (i.e. one week after tumour resection or intravesical therapy) or completed final treatment for NMIBC within the last week

Exclusion Criteria:

* unconscious or confused
* have cognitive impairment
* unable to speak, read and/or write in English
* diagnosed with muscle invasive disease
* unable to provide informed consent

Field test 2:

Inclusion Criteria:

* newly diagnosed NMIBC
* Adult (\>18yrs)
* able to read and understand English
* after imaging or flexible cystoscopy, and before active treatment
* either before endoscopic resection, or more than 4 weeks since endoscopic resection, but before active/ongoing treatment

Exclusion Criteria:

* unconscious or confused
* have cognitive impairment
* unable to speak, read and/or write in English
* diagnosed with muscle invasive disease
* unable to provide informed consent
* currently undergoing active treatment for any bladder cancer, or finished treatment within last 3 years.
Compensation for Smaller Portion Sizes and Portion Size Normality

Reducing food portion size is a potential strategy to reduce energy intake. However it is unclear at what point consumers compensate for reductions in portion size by increasing energy intake from other items. The investigators tested the hypothesis that reductions to food portion size will only result in significant compensatory eating when the reduced portion size is no longer visually perceived as 'normal'. In two within-subjects experiments, participants (Study 1: N = 45, M BMI = 26.9; Study 2: N = 37, M BMI = 26.9; 51% female) were served different sized portions of a lunchtime meal on three occasions: a 'large-normal', a 'small-normal', and a 'smaller than normal' portion. Both the reduction from 'large-normal' to 'small-normal' and from 'small-normal' to 'smaller than normal' portions represented the same change in food volume and energy content (84g, 77kcal Study 1; 98g, 117kcal Study 2). Participants were able to serve themselves additional helpings of the same food (Study 1), or dessert items (Study 2).


Eligibility Criteria:
Inclusion Criteria:

* general liking and willingness to consume the test foods in each study

Exclusion Criteria:

* food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
* a history of eating disorders;
An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients

In patients who underwent sphincter preserving surgery with toal mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal function after stoma closure.


Eligibility Criteria:
Inclusion Criteria:

* rectal cancer patients
* neoadjuvant chemoradiation therapy (+)
* sphincter saving surgery with total mesorectal excision (+)
* temporary loop stoma (+)
* adult who is 17 years or older
* patinet who aggree with our study
* if woman is childbearing age, her pregnancy test shoud be indentified 'negative'

Exclusion Criteria:

* patients who have been enrolled to other clinical studies related to this study
* patients who underwent diverting stoma before neoadjuvant chemoradiation
* temporary end -ostomy (+)
* uncontrolled metabolic or systemic disease
* patients who do not understand the purpose of this study because of dementia or pshycologic problem
* MRSA or Clostridium difficille (+)
* Pregnant or during breast feeding
* serious complication after sphincter saving surgery
Microbiology in Obstructive BIliary Disease

Patients admitted to hospital due to obstructive biliary disease secondary to benign and malign etiologies, undergoing ERCP, will be selected. Bile sample will be taken in ERCP procedure with sterile technique. Its macroscopic appearance will be assessed and biliary culture will be performed.

The sample of biliary aspirate will be assessed as follows.

1. Its macroscopic appearance will be analyzed: yellow, black, or purulent.
2. Biliary culture will be performed; if bacterial growth is observed, its identification will be carried out by means of MALDI-TOF MS mass spectrometry and antibiotic susceptibility tests will be carried out, using the automated VITEK system.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis or suspicion of biliary obstruction of any cause
* Any gender
* Over 18 years of age

Exclusion Criteria:

* Patients referred and previously treated at another hospital/clinic
* Previous ERCP
* Pregnancy
* Patient refusal to enter the study
Diagnosis of Active Tuberculosis by ELISPOT

Recent studies revealed that the ex vivo enzyme-linked immunospot (ELISPOT) assay for gamma interferon is a specific method for contact tracing of Mycobacterium tuberculosis infection. However, its use in endemic area and bacillus Calmette-Guérin (BCG)-vaccinated hosts has not been proved. We hypothesize that the TB-ELISPOT assay can be a rapid and accurate diagnostic tool for active tuberculosis in clinical suspects in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Patients who present with fever or respiratory symptoms (cough, dyspnea, or hemoptysis) lasting for ≥ 2 weeks and have compatible radiographic findings were considered clinical suspects of TB.

Exclusion Criteria:

-
RNA Disruption Assay (RDA) Response Prediction in Neoadjuvant Chemotherapy Breast Cancer Treatment

The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy.

This is important because the earlier non-responders are identified, the greater is the impact of reducing side effects of ineffective treatments.

The study hypothesis is that the RDA score will accurately predict for tumor response after one cycle of chemotherapy.

This prospective clinical trial will determine if the tumor RDA score can predict for pCR after the first, second, and third cycles of chemotherapy in women with breast cancer treated with neoadjuvant therapy. Tumor RDA score will also be measured after the first dose of any new chemotherapy agent if residual palpable disease is present.

Data will be collected until accrual target of 30 patients is met. All patients will undergo core needle biopsy of the breast tumor and analysis of ER, PR, and HER-2-Neu receptors. Patients will receive neoadjuvant therapy as recommended by their treating physicians. All chemotherapy regimens will be acceptable for participation in this study. Usually, these regimens are between 6 to 8 cycles, often with a switch of chemotherapy regimens after 3 to 4 cycles.

Evaluation of tumor size will be determined by 2 axis tumor measurement performed prior to, and after each chemotherapy treatment. The Tumor RDA score will be evaluated by performing fine needle aspiration (FNA) biopsies under local anesthetic, if the tumor is clinically palpable, after the first, second, and third cycles of chemotherapy. Tumor RDA score will also be determined if palpable tumor is present after the first cycle of any second chemotherapy agent.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be female.
* Patients must be 18 years of age or older.
* Patients with stage I, II, or III breast cancer that is greater or equal to 2 cm on clinical examination.
* Patients that have biopsy proven invasive breast cancer diagnosed by core needle biopsy
* Patients who are chemotherapy and radiotherapy naïve for the treatment of the current breast cancer.
* Patients that accept to undergo neoadjuvant chemotherapy.
* Patients with bilateral breast cancer are eligible.
* Patients that understand, accept, and have signed the approved written consent form.
* Patients will need to consent to be part of the study.

Exclusion Criteria:

Patients with one or more of the following conditions are ineligible for this study:

* Patients who have had previous surgery, chemotherapy or radiotherapy for the current breast cancer
* Patients who are pregnant or breast feeding.
* Psychiatric or addictive disorders or conditions or social factors that may preclude the patient from meeting study requirements.
Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Age 18\~75 years old.
3. Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists.
4. Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings.
5. At least one measurable lesion per RECIST v1.1 criteria.
6. ECOG PS score: 0-1.

Exclusion Criteria:

1. Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.
2. Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose.
3. Presence of any active, known autoimmune disease.
Educational and Informative Interventions to Tackle Inappropriate Use of Drugs in Italy

Pharmacological intervention is an essential step in health promotion. However, lots of drugs are often used in inappropriate ways, especially in elderly patients. This study is aiming at evaluating the effectiveness of educational and/or informative interventions addressed to general practitioners and their adult patients in Italy, in order to improve appropriateness of prescribing in primary care.

EDU.RE.DRUG project is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to general practitioners (GPs) and their patients from two Italian regions (Campania and Lombardy), with the objective of investigating the practice of prescribing among GPs to highlight the most frequent events of inappropriateness and to implement ad hoc interventions for GPs and patients.

Appropriateness of prescribing in general practice will be assessed by evaluating selected prescribing, consumption and adherence indicators, using Regional administrative pharmaceutical prescription databases.

Primary care physicians and their patients will be assigned to four trial arms: informative intervention (leaflets and posters for patients), educational intervention (feedback reports and online CME courses for GPs), combined interventions, or no intervention. Intervention effectiveness will be assessed measuring the variation in rates of inappropriate prescription indicators after 1-year of follow-up.

EDU.RE.DRUG project will provide with improvements in the prescribing performance of GPs and in patients' adherence to treatment, with relevant clinical implications in terms of rational and safe use of drugs and optimized patient care, and with economic benefits (optimization of available resources use and savings in direct and indirect health costs).

Eligibility Criteria:
Inclusion Criteria:

* general practitioners of the Italian National Health System (NHS) operating at December 31, 2016 belonging to the 8 Local Health Units involved in the project

Exclusion Criteria:

* primary care pediatricians
GORE® Septal Occluder European Union Clinical Evaluation

The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).


Eligibility Criteria:
Subjects with a PFO less than or equal to 17mm
Metformin Use in Chronic Kidney Disease: The CKD-Met Study

Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit.

Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients.

The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Type 2 diabetes
* Seen by a nephrologist (consultation or hospitalization) between March 2014 and March 2020 in the Department of Nephrology, Lyon Sud university hospital, France

Exclusion Criteria:

* On-going treatment by dialysis
* Kidney transplantation
* Type 1 diabetes
* Missing data (metformin treatment)
Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings

This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.

In the United States, and rural Montana, a substantial health disparity exists for rural youths' mental health and mental health care access. In 2017, nearly a third of all Montana high school students reported being impacted by depression; 21% considered suicide compared to 17% nationally. Over 30% of Montana adolescents indicated drinking alcohol and 20% indicated using marijuana. Rural Montanans face enormous barriers to behavioral health care including low mental health care provider coverage, long distances to adequate care, and stigma. We have developed a culturally and developmentally appropriate Internet-based Cognitive Behavior Therapy (iCBT) program designed to teach skills that address mental and behavioral health challenges common to adolescents. Building on previous development and evaluation of an adult version of iCBT (Thrive), the investigators propose to pilot the newly developed youth version of Thrive (Y-T), a fully automated stand-alone program. Y-T will deliver CBT skills through educational, real life adolescent scenarios, and tailored feedback videos to address symptoms of depression, anxiety and co-occurring (addiction) behaviors. The investigators intend to conduct feasibility analyses of pilot study implementation in school communities. The investigators will document and assess organization-level facilitators and barriers that impact the study processes at each study site. Short-term goal for this research are to understand how to effectively conduct trials within school community settings and to obtain preliminary information on the acceptability and effectiveness of the Y-T program to address depression and anxiety symptoms, and addictive behaviors. The investigators will conduct post-intervention focus groups to assess the program as experienced by participants and insight on the extent of program engagement and learning. The investigators hypothesize that those using Y-T over an 8-week period will report markedly decreased scores on anxiety, depression, and addictive behaviors. The long-term goal is to conduct a larger trial of the program to determine the evidence of impact among youth. Provided that this research demonstrates such programs to be evidence-based, the investigators will work on a broader dissemination plan with the ultimate aim of decreasing mental and behavioral health and respective health care disparities among rural youth.

Eligibility Criteria:
Inclusion Criteria:

* participants are youth enrolled in participating schools
* ages 13 - 18 years old
* have access to electronic device to access iCBT intervention

Exclusion Criteria:

* none.
Hormone and Information Processing Study

The purpose of this study is to examine the effects of testosterone (T) replacement on changes in thinking and memory, as well as mood in older men with mild cognitive impairment (MCI) and low T levels. The study will also examine whether taking testosterone has effects on biological markers related to Alzheimer's disease.

Natural age related declines in testosterone (T) are associated with decreases in cognitive abilities independent of health status. Low T levels over time are associated with increased risk for developing Alzheimer's disease (AD). These findings suggest that men with low T levels are most at risk for age-related cognitive decline and AD and therefore most likely to benefit from T supplementation to prevent the development of AD or age-associated cognitive decline. The current study will assess cognition, mood, and cerebral spinal fluid (CSF) biomarker response to T supplementation in older men with mild cognitive impairment (MCI) and low T levels.

Participants will be randomized to either receive T treatment or a placebo for six months. Participants will come in for about five visits within the span of six months where they will complete cognitive \& memory tests, fill out mood questionnaires, and have their blood drawn to monitor the medication level. A sample of blood will also be taken at one visit to test for apolipoprotein E (APOE), which is a genetic risk factor associated with AD. Participants will have the option to get a spinal tap in order to measure biological markers associated with Alzheimer's disease including beta-amyloid 1-40, 42, total-tau, and phosphorylated-tau-181-231. This will require an additional two visits.

Eligibility Criteria:
Inclusion Criteria:

* Male 60-90 years of age
* Diagnosis of mild cognitive impairment (MCI)
* Low testosterone level
* Primary language is English
* Availability of an informant who knows the participant well enough to answer questions
* Stable medications for the previous 3 months
* Normal complete blood count (CBC), and no clinically significant blood chemistry
* American Urological Association (AUA) symptom score less than or equal to 19
* Body Mass Index (BMI) less than 33 and stable weight in the previous year

Exclusion Criteria:

* Prior history of prostate cancer or prostate specific antigen level greater than 4.0ng/ml
* Peripheral or vascular disease
* Significant history of alcohol abuse, current alcohol abuse (more than 2 drinks per day), or other substance abuse
* History of severe head injury (with loss of consciousness greater than 30 minutes)
* Significant neurological illness, such as Parkinson's disease, seizure disorder, multiple sclerosis, major stoke
* Smokes cigarettes
* Major psychiatric illness, such as schizophrenia or bipolar disorder

Prohibited Medications:

* Anti-convulsants
* Anti-psychotics
* Sedating antihistamines
* Sedative/hypnotics
* Benzodiazepines
* Hormone or testosterone regimens
* Gonadotropin-releasing hormone (GNRH) antagonists
* Flutamide
* Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more