cyrilzakka/clinical-trials huggingface dataset:
Radiomics Analysis of Focal Liver Lesions Based on Contrast-Enhanced Ultrasound Imaging

Contrast-enhanced ultrasound (CEUS) substantially improves the potential of ultrasound (US) for the identification and characterization of focal liver lesions (FLLs). Compared to contrasted-enhanced MRI and CT, it has some unique advantages, such as the absence of ionizing radiation, and easy operability and repeatability. However, the efficacy of CEUS in diagnosing liver lesions is challenged by several factors including being highly dependent on doctor's experience, low signal-to-noise ratio, and low interobserver agreement. Therefore, it is a beneficial attempt to construct an intelligent CEUS diagnosis system using digital information technology. This study aims to collect standard data of CEUS cines recordings and develop deep learning model for accurate segmentation, detection and classification of liver lesions.


Eligibility Criteria:
Inclusion Criteria:

1. patients with a solid liver tumor visible during routine ultrasound and received CEUS.
2. disease history and standard of reference of the lesions can be acquired

Exclusion Criteria:

1. hypersensitivity for ultrasound contrast media
2. pregnant or lactating patients
3. previously treated lesions or local relapse from previously treated lesions
4. diffuse tumors
Persistent Postoperative Pain Incidence With Gabapentin Used

The study's objective will be to evaluate the gabapentine efficiency in orally and long term used after painfully surgeries.

This study will be: controlled, prospective, randomized and double blind.

Its main objective will be to evaluate the pre and postoperative Gabapentin efficiency in orally doses and long term used of it in order to prevent or decrease persistent postoperative pain (PPP) in surgeries with high incidence of it (Pain). Patients will be randomly divided in two branches; one of them will take 600 mg of Gabapentin twice a day and the other group will take Placebo (twice a day also).

Both groups of patients will have to take one pill the day before the surgery (300 mg) and other pill on the surgery day (300mg). After that, the patients will have to continue this treatment during 30 days (two doses per day of Gabapentin or placebo).

After the surgery and after taking the second pill, it will be evaluated:

postoperative sharp pain, sickness, vomiting, sedation and adverse effects.

Patients will be evaluated in the pain treatment office (consulting room) the following times:

1. 30 days after the surgery. (taking drugs suspended)
2. 3 month after the surgery.
3. 6 months after the surgery.
4. 12 months after the surgery

This monitoring treatment will be done in order to evaluate the presence or absence of persistent postoperative pain (PPP).

Eligibility Criteria:
Inclusion Criteria:

* Patients that require persistent painfully surgeries such as breast surgeries (mastectomies and breast implants), herniorrhaphies (not laparoscopical) unilateral or bilateral, amputations of upper and lower limbs and chest surgeries (thoracotomy, thoracoscopy , sternotomies).
* Patients that had already signed the informed consent.
* Patients aged between 21 and 75.
* ASA I - II _ III (Classification system that the American Society of Anesthesiologists (ASA) uses to estimate the anesthesiology risk that patients may suffer)
* BMI, not more than 35 Kg/m2.

Exclusion Criteria:

* Pregnant women
* Patients that suffer liver and renal failure (plasma creatinine over 1.5 mg/ml or creatinine clearance less than 60 ml/min),heart failure or neurological dysfunction.
* Diabetic patients
* Gabapentine allergic patients
Internet-delivered CBT for Adolescents With GAD

This multiple baseline evaluation aims to test the feasibility and preliminary effectiveness of Internet-delivered cognitive behavioral therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD).

This pilot study aims to test Internet-delivered Cognitive Behavioral Therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD)

The study has a single case research design (multiple baseline) and will include 12 participants with GAD according to a semi structured diagnostic interview.

Participants will be randomized to either two, six or ten weeks baseline measurements prior to starting treatment, and will thus work as their own controls.

Primary outcome measures will be collected at 10 weeks after treatment start. Follow-up assessments will be made three month after treatment.

Eligibility Criteria:
Inclusion Criteria:

* A score on the Penn State Worry Questionnaire for Children (PSWQ-C) of \> 30
* Fulfilling DSM-5 criteria for Generalized Anxiety Disorder
* No other disorder or symptoms present in need of more urgent treatment
* Aged between 13 and 17 years
* Ability to read and write in Swedish
* A parent or caregiver that is able to participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
* No other ongoing psychological treatment for any disorder

Exclusion Criteria:

* The presence of symptoms suggestive of a current diagnosis of Autistic Spectrum Disorder, Schizophrenia, Bipolar Disorder, Anorexia Nervosa, Bulimia, or Substance Use Disorder
* Present risk of suicide
* Present occurrence of domestic violence
* Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
Investigating Non-invasive Brain Stimulation to Enhance Fluency in People Who Stutter

This study aims to test whether the application of transcranial direct current stimulation (tDCS) concurrent with fluency training results in improvements in speech fluency in adults with developmental stuttering, measured up to three months after the intervention.

Developmental stuttering affects 5% of children and persists to adulthood in about 1%. Changing the way speech is produced in adults who stutter is a particular challenge for speech and language therapy and there is a need for novel interventions. One such intervention involves the application of transcranial direct current stimulation (tDCS) alongside therapies aimed at improving speech fluency. tDCS influences brain activity by modulating neuronal plasticity through the application of weak electrical currents across the brain. Pairing tDCS with speech therapy has potential for producing larger or longer lasting effects and reducing time spent in therapy.

The study will evaluate the potential of tDCS combined with speech fluency training to improve outcomes in people who stutter (PWS). PWS will have this training while receiving tDCS for five days (1 milliampere \[mA\] for 20 mins per day) in a double-blind randomized controlled trial. Outcomes will be measured in terms of changes to stuttering severity.

An additional research questions is how changes in interactions between sensory and motor brain regions relate to changes in speech fluency in PWS. MRI will be used to measure brain structure and function and the vocal tract during speech production. Transcranial magnetic stimulation (TMS) will assess motor excitability before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Diagnosed with developmental stuttering of mild-moderate or greater severity
* Native speaker of English
* Normal or corrected-to-normal vision
* Normal hearing

Exclusion Criteria:

* Speech, language or communication disorder other than developmental stuttering.
* Contraindication to brain stimulation (tDCS or TMS)
* Contraindication to MRI
* History of drug abuse
* History of a neurological or psychiatric illness
* Any previous neurosurgical procedures
* Taking prescription or over-the-counter medication that may affect brain function (for example, anti-depressants)
* Family history of epilepsy (first degree relative)
* Severe claustrophobia (as they may be unable to tolerate scanner)
Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas

To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects from 40 years up to 90 years old
* Diagnosis of primary open angle glaucoma (POAG) and pseudo-exfoliative glaucoma
* Subject is able to understand and sign a written informed consent form
* Subject who underwent SST implantation and agreed to come for the cross-sectional follow-up

Exclusion Criteria:

* Close angle forms of glaucoma
* Congenital or developmental glaucoma
* Pseudophakic with an anterior chamber intraocular lens (IOL), iris fixed IOL, or implantable contact lens (ICL)
* Prior glaucoma procedures such as Selective Laser Trabeculoplasty (SLT), Microinvasive Glaucoma Surgery (MIGS) or Episcleral Shunts
* History of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye
* Chronic ocular inflammatory disease, or clinically significant ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis).
* Any condition that, in the Investigator´s opinion, can interfere with full participation in the study, including study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data.
Stereotactic Body Radiotherapy for the Treatment of OPD

HALT is a phase II, randomised multi-centre study with integrated seamless continuation to phase III trial following acceptable safety and feasibility assessment.

HALT aims to recruit 110 patients with mutation positive advanced NSCLC with oligoprogressive disease (OPD) following initial response to a Tyrosine Kinase Inhibitor (TKI).

Eligible patients will be randomised to receive either SBRT or no SBRT at a ratio of 2:1 (SBRT : no SBRT), with all patients continuing to receive background treatment with TKI therapy as clinically indicated and as per standard care. Patients randomised to receive SBRT will receive a dose and fractionation schedule dependent on OPD lesion site and proximity to critical normal tissues. All patients will be seen 8 weeks post randomisation, then 3 monthly in line with routine care.

HALT aims to assess whether in patients with mutation positive advanced NSCLC the use of SBRT to ≤ 3 sites of OPD with continuation of TKI improves progression-free survival (PFS) compared with continuation of TKI alone.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 16 years of age
2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy
3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI)
4. Confirmed OPD defined as ≤ 5 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual multi-disciplinary team (MDT) and in accordance with the HALT Radiotherapy planning and delivery guidance document.
5. Adequate baseline organ function to allow SBRT to all relevant targets
6. Predicted life expectancy ≥ 6 months
7. Karnofsky Index ≥ 60% and ECOG 0-2
8. Provision of written informed consent

Exclusion Criteria:

1. \> 5 extracranial sites of progressive disease
2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or SRS. Previously treated brain metastases (i.e palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for ≥ 6 months are permissible.
3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT. Suitability of lesions for ablative SBRT as part of the trial defined in section 4.1 of this document and will be determined by the HALT virtual MDT
4. Co-morbidities considered clinically precluding the safe use of SBRT (as detailed in the HALT radiotherapy planning and delivery guidelines).
5. Any psychological, sociological or geographical issue potentially hampering compliance with the study
6. Pregnancy
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic (\> 6 months), hepatic impairment.
* In the opinion of the Investigator, be in good health.

Exclusion Criteria:

* Severe hepatic encephalopathy.
* Prior placement of a portosystemic shunt.
* Hepatorenal or hepatopulmonary syndrome.
* Suspicion of hepatocellular carcinoma.
Pain Management in Cancer Patients Using a Mobile Application

The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients, 18 years and above suffering from solid-organ cancer.
* Diagnosed with moderate or severe cancer pain (i.e. pain intensity score of at least 4/10 on numeric rating scale (NRS)) at the Massachusetts General Hospital (MGH) Palliative Care Center, as determined by the patient's care provider at the MGH Palliative Care Center. Subjects do not need to experience a specific nature of pain for eligibility.
* Patients must be ambulatory and not currently admitted to the hospital at time of enrollment.
* Must have a smart phone and be willing to download the study application (Phase II only)
* Must be able to read and speak English.

Exclusion Criteria:

* Life expectancy less than 2-months as determined by the palliative care provider
* Significant medical or psychiatric co-morbidities (other than depression or anxiety) or cognitive impediments that would prevent participant from being able to utilize the program
* Known history of substance abuse
* Patients currently on investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are main outcomes of this intervention.
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant

Children with chronic kidney disease, even after transplantation, may be at risk for bone problems due to an imbalance of calcium and phosphorus in the blood, especially as their kidneys progressively fail to function. While some drug and diet treatments are available to prevent such bone disease, many children refuse to take them due to bad taste and tummy cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can form in the blood vessels, eventually clogging them and resulting in heart problems. Investigators are studying possible new methods to help the kidneys maintain a normal balance of nutrients in the blood which is important for growing healthy bones and the prevention of side effects in blood vessels that can lead to heart disease. One method is to improve the team work of a hormone FGF-23 and a protein called Klotho that together stimulate the kidneys to increase phosphate removal. Investigators propose that this problem may be due to low blood zinc levels which often occur in children with kidney disease. Thus, in this study, investigators propose to first measure zinc in blood from children with chronic kidney disease (CKD) or who have had kidney transplants to assess zinc and phosphate status, the hormone FGF-23 and its assistant Klotho. If zinc status is low, the children will receive zinc supplementation for 3 months. After treatment with zinc, the same blood measurements will be repeated to determine if the zinc supplements have helped the hormones to remove phosphate from the body. If this pilot project is successful, investigators will then consider a larger scale project involving adult patients as well as pediatric patients from other pediatric centers. This project will also guide investigators as to whether they need to introduce zinc measurements as part of routine testing of CKD and transplant patients. In addition to measuring zinc levels in study participants, trace elements (TE) will also be measured. These include heavy metals such as cadmium, chromium, nickel, vanadium, copper, lead, manganese and selenium. Very little is known about levels and metabolism of TE in CKD especially before dialysis. In adults, cadmium, chromium, nickel, and vanadium probably accumulate in hemodialysis patients, while copper and lead may accumulate. Manganese, selenium are probably deficient. The study will allow investigators to obtain the information about TE in this group of pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Children between 4 and 18 years of age; diagnosis of CKD; renal transplant recipient with declining renal function (eGFR\<90 ml/min/1.73 m2).

Exclusion Criteria:

* Children with CKD or kidney transplant younger than 4 years. Kidney transplant recipients with eGFR\>90 ml/min/1.73 m2.
Advanced Renal Cell Carcinoma, With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy

The primary objective of this prospective, observational, post-marketing study is to evaluate the patient characteristics, pre-treatment and treatment duration in Renal Cell Carcinoma (RCC) patients who are candidates for systematic therapy and in whom a decision to treat with Nexavar® has been made under real-life practice settings and approved reimbursement restriction in Taiwan. Therefore, the main objective of the study is to collect data on:

Prescription pattern: to determine the factors affecting compliance and duration of treatment with special attention given to education status, demography, disease details, pre-treatment, concomitant medication and other baseline data

Nexavar® treatment and efficacy data

Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Nexavar® under Taiwan reimbursement guideline
* Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

* Exclusion criteria must follow the approved local product information.
* Patients were lost to follow-up if no follow-up visit and no final assessment of Nexavar® was documented.
B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients

The primary aim was to measure the effect of green tea extract, tyrosine and caffeine on energy expenditure, appetite ratings and spontaneous energy intake together with recording of side effects in healthy normal weight subjects.

Background: Long-term weight maintenance of a weight loss is often unsuccessful. Often a weight regain is observed in most studies that could indicate that most subjects are not able to change their eating habits. There is a need for simple and safe methods to prevent weight gain and re-gain i.e. by increasing thermogenesis and decrease spontaneous energy intake (EI). Studies have shown that nutritional and food-related non-nutritional factors influence the adjustment of EI and EE as the compounds can enhance the diet-induced thermogenesis (DIT) and suppress appetite.

Method: The present study was designed as a 4-way crossover, randomised, placebo controlled, dou-ble-blind study. Each treatment was separated by \>3 d washout period. All treatments were administered as tablets containing either 500 mg green tea extract (whereof 125 mg cate-chins), 400 mg tyrosine, 50 mg anhydrous caffeine, or placebo.

on each test day body weight and composition was assessed. All participants underwent a 4.5-h assessment of energy expenditure by indirect calorimetry in a ventilated hood. Energy intake recorded of an ad libitum pasta salad brunch served after the last hood measurement

Subjects: Twelve healthy lean (20\<BMI\<25) weight stable non-smoking subjects between 18-40 years of age were tested 4 times each with a wash-out period of at least 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Twelve healthy and normal-weight men (age: 23.72.6 y, BMI: 22.41.8 kg/m2) participated in the study. They were weight stable (within 3-kg in last 3 mo), non-smoking, non-athletic, and had no use of dietary supplements or frequent use of medication.

Exclusion Criteria:

-
Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

Endometrial cancer (EC) is the most common gynecological malignancy in high-income countries. Prognosis and treatment are dictated by cancer histological subtype and grade coupled with surgical staging as described by Surgical International Federation of Gynecology and Obstetrics (FIGO) staging system. Surgery is the elective standard treatment and used for staging of EC. The purpose of this study is to collect images from a simultaneous PET/MRI study from which to extrapolate a preoperative, non-invasive, prognostic model.

Magnetic resonance imaging (MRI) is the most frequently used imaging tool in preoperative staging of endometrial cancer. FDG-PET has demonstrated higher sensitivity than MRI in detecting nodal involvement and metastatic disease and is currently used in adjunction to MRI. Distinct MRI and FDG-PET parameters correlate well with tumor aggressiveness and can and have been used as prognostic factors. The Investigators believe that the combination of data from these two imaging techniques, from which different derived tumor features can be extrapolated, can stratify patients in high-risk and low-risk groups already preoperatively. The aim of combined techniques is to collect large amounts of data leveraging advantages of both modalities (MR's strengths in local staging and PET's strengths in nodal staging) in a single scan from which to extrapolate a preoperative, non-invasive, prognostic model.

Eligibility Criteria:
Inclusion Criteria:

* histopathological confirmation of a primary endometrial cancer
* age \> 18 years
* no contraindication to surgery (comorbidity, contraindication or lack of consent)
* no contraindication to preoperative imaging
* visible tumor at imaging
* signed inform consent.

Exclusion Criteria:

* patients unsuitable for surgical intervention (comorbidity, contraindication or lack of consent, poor performance status)
* age \< 18 years, c) inability to complete the needed imaging examination (ie, severe claustrophobia)
* any additional medical condition that may significantly interfere with study compliance
* all the contraindication for MRI (ie, pacemaker).