cyrilzakka/clinical-trials huggingface dataset:
Non-invasive MRI Subclassification of Heptocellular Carcinoma - HepCaSt-Study

Non-invasive MRI subclassification of Heptocellular Carcinoma - HepCaSt-Study

Hepatocellular carcinomas (HCCs) are a heterogeneous group of tumor subtypes with a different response behavior and prognosis. As a reaction, the World Health Organization (WHO) in its 5th version (updated in 2019) classifies no more two but eight subtypes, each with a different tumor biology and outcome. The new classification may serve as a key factor optimizing a more personalized therapeutic approach and therefore, especially diagnostic disciplines have to implement these new subtypes as soon as possible into their daily clinical routine algorithms.

Imaging does play a key role in this situation. Newer and advanced MRI techniques allow a precise tissue characterization. Furthermore, with the help of latest generation hepatobiliary contrast agents like the usage of Gd-EOB (Primovist) it is possible to quantify and measure the organ function and specific uptake behavior of focal liver lesions. Another approach that hold promise for advancing the characterization of HCCs heterogeneity is the use and development of artificial intelligence (AI)-based image postprocessing algorithms including radiomics analysis.

To date there aren't any established imaging features correlating with any of the new WHO HCC-subtypes. The goal of our project is to identify imaging biomarkers correlating with the new HCC-subtypes, helping to classify them noninvasively. As a next step with the help of our collaborators we will facilitate a radiological-pathological reference database. In a third step and with the help of the data we curated we will try to identify morphologic imaging characteristics by the use of AI-based post-processing algorithms to classify the subtypes noninvasively and to predict / estimate patients individual therapy response and prognosis. The last challenge will be to implement these algorithms into daily clinical routine, we therefore have to identify interface dilemmas and present smart solutions to solve them.

We are convinced that by implementing the updated WHO-criteria into clinical workflows current believes and guidelines in the diagnosis and therapy of HCC will change. MRI HCC imaging with Primovist will play a key role in this project. The results of our project may provide the knowledge to represent as a cornerstone in imaging and therapy assessment of HCC to improve a personalized therapy approach.

Eligibility Criteria:
Inclusion Criteria:

Patients with hisopathologically confirmed HCC and MRI in domo with the standard high-end MRI Primovist study protocol.

Exclusion Criteria:

Unmet inclusion criteria. MRI contraindications. Patients declines.
Laparoscopic Donor Nephrectomy Score, a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy

The goal of this multicenter observational study is to develope and validate a new scoring system for preoperative prediction of difficulty of Laparoscopic Donor Nephrectomy. Healthy living kidney donors will be enrolled. The main questions it aims to answer are: 1) can the investigators predict difficulty of the operation ? 2) Can the investigators score difficulty based on this new scoring system? Difficulty of LDN will be graded by the operating surgeon at the end of the operation based on intraoperative predefined parameters. All operations will be blindly scored by the operating surgeon, while one radiologist will blindly review all preoperative CT scans. LAPDOCTOR scores will be compared with the degrees of difficulty assigned by the operating surgeon to investigate the match rate.

The LAPDOCTOR scoring programme calculates the score based on presence, absence of certain characteristics (Sex, BMI, different radiologic measurements, etc.). A score of 1 to 2 is assigned to each characteristics . Difficulty is graded as standard when the sum is between 11 and 18, moderately difficult between 19 and 25, very difficult between 26 and 33). At the end of the operation the donor surgeon will score the difficulty assigning a score of 1 to 3 to each phase of the operation, the resulting score will define again three degree of difficulty (standard 1-8, moderately difficult 9-16, very difficult 17-24.

Eligibility Criteria:
Inclusion Criteria:

- Age of donor ≥ 18 yrs (minimum 18, maximum , deemed suitable for donation at the end of work-up

Exclusion Criteria:

* age\< 18 yrs
* hypertension with organ damage
* unable to express proper consent to procedure
* evidence of coercion
* drug abuse
* evidence of malignancy
* pregnancy
* major respiratory or cardiovascular risk
* diabetes mellitus
* renal disease
* systemic disease with renal involvement
* thrombophilia
* BMI \>35
* active infection
* hepatitis B, hepatitis C and HIV
Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.

An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar prevention and reduction and acceleration of healing. The trial has an additional objective to evaluate several different scar assessment techniques that can be used in future clinical trials in the prevention and reduction of scarring.

Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject receives a total of 6 wounds, two incisions and four punch biopsies. Each subject serves as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing/scarring. Healed scars from incisional wounds excised from Arm 1 and Arm 2 after 6 months for histological analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinically healthy, male and female subjects aged 60 years and over. All females will be at least 2 years post menopausal.
* Weight between 50 and 150kg or a body mass index within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 15 - 35 kg/m2.

Exclusion Criteria:

* Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.
* Subjects with a personal history of a bleeding disorder.
* Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing the acute wounds or involves the areas to be examined in this trial.
* Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.
* Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.
* Subjects with any clinically significant abnormality following review of pre trial laboratory data and physical examination (see above).
* Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, hormone replacement therapy (HRT) or anti-coagulant drugs in the thirty days prior to Day 0.
* Subjects who have evidence of drug abuse.
* Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.
* Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.
* Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group.
* In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason.
Feasibility Study of Non-invasive and Continuous Measurement of Blood Pressure and Cardiac Output: Comparison to Non-invasive and Non-continuous Measurements

The objectives of this clinical trial is to validate a S/W application to compare the calculations of Hemodynamic parameters like Continuous blood pressure (BP) and Continuous cardiac output (CO). This Hemodynamic parameters are computed from Pulse Oximeter (PhotoPlethysmograph or PPG) signal with results obtained by NIBP intermittent measurements and Echocardiography. The first phase of the study will be done on 10 patients of the Cardiology dept.- Cardiac ICU, that have routine measurements of BP and CO using Echocardiography.

The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and a Smartphone S/W application that serves as the Hemodynamic calculator. The S/W application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.

The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like (Blood Pressure) BP and CO in a continuous and graphical way on a standard Android Smartphone. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.

HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.


Eligibility Criteria:
Inclusion Criteria:

* Male and females
* Between the ages of 20-70 years old

Exclusion Criteria:

* Over 70 years old
* under 20 years old
* Supportive blood pressure
* Severe Sepsis
* Ventilated patients
* Supported by Amines
* Patients in state of Shock
A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative)
* Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use);
* Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners for a 12-month duration after the last UCART19 administration.

Exclusion Criteria:

- No exclusion criteria for this study
Influences of Phenylephrine, Dopamine and Ephedrine on Stroke Volume Variation and Pulse Pressure Variation

Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.

Pulse pressure variation (PPV) and stroke volume variation (SVV) during mechanical ventilation have been shown to be effective parameters to predict preload responsiveness. Although induced hypertension decreases PPV and SVV, the influences of phenylephrine, dopamine and ephedrine on PPV and SVV are unknown.

Eligibility Criteria:
Inclusion Criteria:

* Their American Society of Anesthesiologists (ASA) physical status was 1 or 2
* Body mass index (BMI) ranged from 18 to 26
* None of the patients had known diabetes mellitus, hypertension, cardiovascular, pulmonary, endocrinological, neurological diseases, or diseases that influenced intravascular fluid volume or balance
* All patients had a preoperative fast for at least 8 h and routine atropine intramuscular injection

Exclusion Criteria:

* Persistent arrhythmias
* Intraoperative application of vasoactive drugs except phenylephrine, dopamine and ephedrine
Tumor Microenvironment Surveillance on Simultaneous Liver Metastases Extensive Stage Small Cell Lung Cancer

The purpose of the trial is to detect tumor microenvironment on Extensive Stage Small Cell Lung Cancer with simultaneous liver metastases who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18， Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Exclusion Criteria:

- Patients with contraindication of chemotherapy Pregnant or breast feeding women
Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.

In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by CT scans, and the maximum diameter of nodule is between 8mm and 3cm;
* Male or female, with age of 18\~80 years;
* Agree to take the pulmonary nodule biopsy, and sign the Informed Consent.

Exclusion Criteria:

* With severe comorbidities and unable to participate in this study;
* Diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment;
* Pregnant or maternal women;
* Diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites;
* Unable for regular follow-ups according to the research protocol;
* Blood sample is not qualified for biomarker testing.
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI

Background:

Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits for patients with manifest chronic cardiometabolic disease, such as type 2 diabets mellitus (T2DM) and myocardial infarction (MI). However, large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors.

Design:

This is a double-blind, randomized, placebo-controlled clinical trial. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry and with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, for patients diagnosed with T2DM and/or MI. Patients will be randomized 1:1:1:1 to a three-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after three months. The major secondary endpoint is exercise capacity at three months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, glycaemia, and gut microbiota composition after three months.

Implications:

Secondary prevention after cardiometabolic disease, including T2DM and MI, has improved during the last decades but diabetes complications, readmissions and cadiovascular related deaths following these conditions remain large health care challenges. Controlling hyperlipidemia, hyperglycaemia, hypertension and inflammation is critical to preventing (new) cardiovascular events, but novel pharmacological treatments for these conditions are expensive and associated with negative side effects. If bilberry and/or oat, in addition to standard medical therapy, can lower LDL cholesterol and inflammation more than standard therapy alone, this could be a cost-effective and safe dietary strategy for secondary prevention in high-risk patients or risk prevention in subjects with T2DM.


Eligibility Criteria:
Inclusion criteria

* Confirmed T2DM diagnosis (any treatment modality accepted) and/or within 3 years post STEMI or NSTEMI
* Completed coronary angiography/PCI
* Male and female subjects ≥18 years
* Allocated to atorvastatin at a daily dose of 80 mg (only eligible for patients enrolled up to 7 days post MI and not for T2D subjects)
* Written informed consent

Exclusion criteria

* Emergency coronary artery bypass grafting
* \<18 years of age
* LDL cholesterol \<2.0 mmol/L
* Daily intake or the intent to initiate daily intake of bilberry in any form or daily intake of \>15 g of oatmeal or equivalent
* Food allergy/intolerance to gluten, bilberries or legumes
* Previous randomization in the BioDiaMI trial
* Inability to provide informed consent
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis

The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter.
2. Age 30-85 years, inclusive.
3. Good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

Exclusion Criteria:

1. Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease.
2. Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism.
3. Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within 180 days prior to the Baseline Visit.
4. Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.
Home Test of New Sound Processor

The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject (18-\<70 years of age)
* At least 12 months experience from using a Baha Connect system (percutaneous Baha)
* Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist
* Willing and able to provide written informed consent

Exclusion Criteria:

* Signs of infection around the implant site
* Unable to follow investigational procedures
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)
* diagnosed with type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

Exclusion Criteria:

* Type 1 diabetes mellitus,
* FPG \>240 mg/dL before treatment started
* Subjects who have history of unstable or rapidly progressing renal disease
* Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
* Significant cardiovascular history