cyrilzakka/clinical-trials huggingface dataset:
Non-Invasive Quantitative Imaging of Human Local Arterial Wall Elasticity Using Supersonic Shear Imaging

Arterial stiffness is associated with increased risk of cardiovascular events and death.

Most of existing technique need dedicated device for arterial stiffness evaluation and indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel non-invasive technique based on remote palpation of biological tissues that can image with very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic properties of tissues. The investigators goal was to apply this SSI technique for arterial stiffness evaluation and local pulse wave velocity (PWV) calculation.

As a first step, the primary goal of this study is to establish normal values of local pulse wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy volunteers.

Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures.

Eligibility Criteria:
Inclusion criteria for Healthy Volunteers

* Healthy volunteers between 18 and 70 years old of two sexes.
* Caucasian origin
* No tobacco or stopped for more than 5 years
* BMI between 18 and 30 kg/m2.
* Blood pressure after 5 minutes of rest \< 140 and 90 mmHg.
* Biological test (haematological biochemistry test in blood , urine test and toxicology tests are all normal) ECG, Blood pressure and Heart rhythm normal.
* All volunteers received information on the research and signed the consent form.
* Health system protection required

Inclusion criteria for patient :

* Age between, 18 et 70 years old for the two sexes
* Presence of two major criteria of Villefranche classification (Am J Med Genet 1998 ;77:31-7) and/or heterozygote pathogen mutation of COL3A1 gene.
* At least 4cm long normal arterial segment (carotid or femoral) analyzed by mode B echograph.
* All patient received information on the research and signed the consent form.
* Health system protection required

General Exclusion Criteria :

* Pregnancy
* Echograph gel allergy
* Local Artery disease (dissection or thrombosis)
* Arrhythmia
* No health insurance coverage
* Incapacity or refused to sign the consent form

Exclusion criteria for Healthy volunteers

* Acute or Chronic Systemic disease (atherosclerosis)
* Alcohol abuse or drug abuse (cocaine,cannabis,etc..)
* Active or past tobacco
* Hypercholesterolemia (LDLc \>1.09 g/l)
* Exclusion period according to the national record for volunteer of clinical trial.

Exclusion criteria for Patients

* No intact (carotid or femoral) segment for SSI analysis
* AT2 inhibitors or Beta blockers treatment will be notified but are not considered as exclusion criteria.
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)

The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).


Eligibility Criteria:
Inclusion Criteria:

1. Participants with PTCL or CTCL.
A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy

In this study, about 200 pure GGO in women preparing for pregnancy will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion in women preparing for pregnancy and provide evidence for GGO treatment.


Eligibility Criteria:
Inclusion Criteria:

- 20-45 years' old found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains Diameter of GGO \> 5mm and \< 3cm

Exclusion Criteria:

- receiving immunosuppressor or steriods receiving chemo- or radio- therapy can not receive regular follow-up
To Investigate the Effect of Early Community-care Program on Fracture Hip Patient

The early community-care program is well-known rehabiliation for the fracture hip patient. For the discharged fracture hip patient from hospital, it is worth to investigate the effect of early mobilization program to improve their physical and psychological aspects.

60 fractured hip patient will randomized allocated into intervention group and control group.

The community-care include nursing care, physiotherapy and home modification according to the condition of the patient.

The intervention will received community-care program for 12 weeks. Two sessions per week and total 24 sessions.

The control group will receive the traditional medication. The outcome measure include elderly mobility scale and happiness scale. The measurement will take at initial and completion of the program.

SPSS will be used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* fracture hip patients discharged from queen mary hospital

Exclusion Criteria:

* cognitive impairment
Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major

Myocardial iron overload is the leading cause of death in patients with beta-thalassemia major (TM). Therapy with deferoxamine (DFO) combined with deferiprone (DFP) reduces myocardial iron and improves cardiac function. However, the prognosis for TM patients with established cardiac disease switched from DFO monotherapy to combined DFP/DFO chelation is unknown. Twenty-eight TM patients with cardiac disease were enrolled in a prospective study lasting 42±6 months. Fifteen (9 high-ferritin and 6 low-ferritin) were placed on DFP/DFO (DFP, 75 mg/kg t.i.d.; DFO, 40-50 mg/kg over 8-12 h at night 5-7 d/wk), while 13 (5 high- and 8 low-ferritin) received DFO alone. No cardiac events were observed among high-ferritin patients on combination therapy, whereas 4 cardiac events (p=0.0049), including three deaths, occurred in high-ferritin patients on DFO monotherapy. These findings demonstrate that in TM patients with well-established cardiac disease combined iron-chelation therapy with DFP/DFO is superior to DFO monotherapy.


Eligibility Criteria:
Inclusion Criteria:

Cardiomyopathy secondary to iron overload

Exclusion Criteria:

Heart failure
Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders

The primary objectives are to evaluate the safety and efficacy of infusion of the third party fully-characterized clonally derived fetal MSCs (cfMSCs) for the control of severe symptoms associated with acute and chronic immune-related disorders and tissue damage.

MSCs have been extensively studied and clinically evaluated for the treatment of autoimmune diseases and graft versus host disease (GVHD) after hematopoietic stem cell transplantation (HSCT). The variable source of MSCs and the lack of consistency of primary tissue-derived MSCs are major obstacles to reliable translational applications of such therapeutic cell products. Fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential and express rich levels of various growth factors, and thus can achieve quality consistency. Careful evaluation of fMSCs in clinical studies has not been conducted. Autoimmune diseases involve aberrant immune responses that harm tissues and organs. GVHD is a serious and often fatal problem associated with HSCT. MSCs have immunomodulatory and immunosuppressive effects. In many studies, MSCs have demonstrated promising beneficial effects that reduce severe autoimmune reactions, diminish symptoms of chronic GvHD and therapy-resistant acute GvHD including steroid-resistant GVHD. The safety and therapeutic effects of phenotype and functionally characterized fMSCs still require extensive clinical evaluation. This study aims to assess the safety and the potential beneficial effects of infusion of various dosages of third party fMSCs for the control of severe symptoms associated with acute and chronic immune-related disorders.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent.
2. No available alternative treatment that can reduce the symptoms
3. Patients are required to meet the following inclusion criteria:

   * Any patient that has clinically documented abnormal immune or age-related disorders including acute and chronic GVHD. Patients may receive best available treatment for the control of disease symptoms.
   * Patients with symptoms associated with genetic defects or infectious diseases are not eligible.

Exclusion Criteria:

1. Inability to give informed consent.
2. Patients with ongoing infection or history of cancer.
3. Patients with poor clinical conditions with the life expectancy of less than 14 days.
4. Pregnancy.
Oral Olanzapine Versus Haloperidol or Diazepam

The purpose of this study is to determine whether oral olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or diazepam when used in the management of acute agitation in the emergency.

1. Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.
2. The multi-centre Randomised Clinical Trial will determine the safety and efficacy of oral olanzapine, in comparison with conventional medicines (haloperidol or diazepam) in a three-arm comparison for the sedation of acutely agitated patients in AEDs. Specifically, we aim to determine if administration of oral olanzapine (a)is more effective than sedation with oral haloperidol or oral diazepam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and diazepam arms with respect to safety, efficacy and adverse events.

Investigate potential variables leading to AED attendance and/or admission requiring oral sedation. These may include patient demographic and regular medications and adherence.

Eligibility Criteria:
Inclusion Criteria:

* Accident \& Emergency Department patients
* Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.

Exclusion Criteria:

* known hypersensitivity or contraindication to the study drugs
* reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
* known pregnancy
* acute alcohol withdrawal
* refusal to take oral medication
* patients from correctional facilities
Retinoic Acid Homeostasis in Neuropsychiatric Diseases

It is hypothesized, that local retinoic acid (RA) homeostasis is functionally involved in the pathophysiology of depression. In a cross-sectional (and partly longitudinal) analysis, serum RA status will be assessed in healthy controls and subjects with Major Depression, Alzheimer's disease, alcoholism and in subjects with schizophrenia.

Retinoids comprise of a group of small-molecule derivatives of Vitamin A with retinoic acid (RA) representing the biologically most active endogenous form. RA has multiple functions central nervous system (CNS). It is hypothesized, that local RA homeostasis is functionally involved in the pathophysiology of numerous neuropsychiatric diseases.

Eligibility Criteria:
MDD-Group

Inclusion Criteria:

* depressive episode in the context of unipolar major depression
* at least 18 points or more on the BDI and HAMD-17

Exclusion Criteria:

* additional or comorbid axis-I or axis-II disorder
* current history of any neurological or other serious medical condition
* any psychopharmacological treatment or substance use within the last two weeks or 5 half-lives (whichever is longer) of the respective substance
* any oral or topical application of retinoid-containing preparations within the last 3 months

AD-Group

Inclusion Criteria:

* diagnosed AD

Exclusion Criteria:

* any other neurodegenerative disorder
* any oral or topical application of retinoid-containing preparations within the last 3 months

Schizophrenia-Group

Inclusion Criteria:

* subjects with schizophrenia
* intended therapy with clozapine, olanzapine or aripiprazole
* BMI: 18 - 29,9 kg/m2

Exclusion Criteria:

* presence of diabetes or pathological glucose tolerance
* presence of and chronic inflammatory disease
* any psychopharmacological treatment of clozapine, olanzapine or aripiprazole within the last 3 months
* any oral or topical application of retinoid-containing preparations within the last 3 months

Alcoholism-Group

Inclusion Criteria:

* subjects with alcoholism who either still consume alcohol or are abstinent for at least 4 weeks

Exclusion Criteria:

* any oral or topical application of retinoid-containing preparations within the last 3 months
* current history of any neurological or other serious medical condition despite liver diseases
Dysphagia Severity and Functional Independence Level

Functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. The functional independence depends on physical, social, cognitive and psychological abilities of the person. Therefore, full functional independence requires the harmony of all these parameters.

Dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. Muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. Pain and fatigue are also frequently observe. These patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. Life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. Both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. Neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding.

Dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. In a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. Decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. Other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (ADL). These studies also suggest that dysphagia may be associated with functional independence in geriatric group. Therefore, functional independence may also reduce in patients with neurogenic dysphagia. However, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. Therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18-65 years
* independent to walk 3 meters
* underwent a Modified Barium Swallowing Study (MBSS).

Exclusion Criteria:

* having any cervical pathology that may affect swallowing physiology,
* history of rheumatological diseases
* having any orthopedic surgery in the previous 6 months
* using a wheelchair.
The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot

The flatfoot is one of the most common diagnosis in foot. The main goals of its orthotic intervention in adult population are the control of the rearfoot and midfoot movement, the affection of the forefoot position and the minimalization of painful deformities. However, only low-level evidence exists proving the positive effect of orthotic insoles in these patients. The concept of sensorimotor insoles describes besides the simple mechanical correction also the targeted modulation of activity of muscles participated on the correct foot function. The aim of the project is to assess the influence of customized sensorimotor insoles on the lower limbs' kinematics and the activity of lower limbs' muscles in people with diagnosed flexible flatfoot.

The study is designed as a crossover interventional study with experimental and control group (allocation ratio 1:1). Participants' lower limbs' kinematics and muscles activity will be assessed on the baseline measurement, immediately after and 3 months after the intervention with sensorimotor insoles in the experimental group. Also, the subjective perceived effect of intervention will be assessed through the research. After a washout period, experimental and control group will swap their roles and another period of 3 months will follow. Same parameters will be assessed both at the beginning and in the end of each period.


Eligibility Criteria:
Inclusion Criteria:

* ability to stand and walk without aid or support
* flat foot deformity confirmed by the Foot Posture Index (FPI-6) score \>5 and/or the normalised navicular height truncated \<0.21

Exclusion Criteria:

* congenital and/or acquired neuromuscular or orthopaedic impairments that severely limit mobility and/or balance
* any acute pain while standing and/or walking
Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)

In this Randomized Controlled Trial (RCT) we want to study the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype.

Our primary endpoints are changes in the concentration of EPA and DHA in plasma.

This is a randomized double-blinded controlled trial (randomized 1:1). Study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides \> 1.7 mmol/L and waist measurement \> 80 cm (women) and \> 94 cm (men).

Study design:

* 3 weeks run-in-period where all participants consume control capsules every morning.
* Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.

The intervention oil is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils.

Power calculation and sample size:

It was expected a difference of 15% in n-3 between the groups after the intervention (Østbye et al. 2019, doi:10.1017/S0007114519001478).

The level of significance was set to 5% (two-sided) and the power to 80%. A total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).

Eligibility Criteria:
Inclusion Criteria:

* Triglycerides \> 1.7 mmol/L
* Waist measurement \> 80 cm (women) and \> 94 cm (men)

Exclusion Criteria:

* Chronic disease (liver/kidney/metabolism)
* Ongoing active cancer treatment
* Excessive alcohol consumption (\>40g/day)
* Pregnant/breastfeeding or planned pregnancy during the intervention
* High intake of fish (\>3 weekly meals)
* Level of free thyroxine (T4) and triiodothyronine (T3) outside reference ranges.
* Hypertension (≥ 160/ 100 mmHg)
* Total cholesterol \> 7.8 mmol/L
* Blood donation during the intervention period
* Difficulty following the protocol
* Smoking or sniffing
* Regular use (\> 1 day/week) of anti-inflammatory drugs
* Regular use of omega-3 supplements/cod liver oil
* Drug use other than stable use of statins, hypertension drugs (Ca antagonists, diuretics and beta blockers).
* Hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod
Efficiency of AI Reporting (EAIR).

While there are features on a CCTA that are correlated with plaque vulnerability and can be reported on, this is not always done. This is important as it is thought that vulnerable plaques present the greatest risk of myocardial infarction. This study will assess the correlation between software and human classification of these plaques, as well as demonstrating the time efficiency of AI reporting when compared to a clinician.

This is a retrospective observational study. It will be performed at London Northwest Healthcare NHS Trust (LNWH -Northwick Park Hospital (NPH), Harrow and Ealing Hospital, Southall).

Patients who have had a CCTA in the last 12 months will be contacted about the study. Their CCTA scans will already have been reported and the patient aware of the results. After giving informed consent, 100 patients will have their clinical CCTA images uploaded to the Artrya Salix software for analysis. Simultaneously the images will be re-reported by the physician as per standard of care. Both reports will be obtained and any differences noted. The time the images are sent to Artrya Salix and report received will be recorded. The time the clinician opens the image to analyse and the time when the report is complete will also be recorded using a stopwatch. All images will be analysed by both expert readers to take account of inter-observer variability. The first 30 patients will be treated as a pilot for the study and after their recruitment and image upload and analysis, the team will meet to discuss any issues that have arisen.

During the analysis, any patient who has plaque identified by the software or expert reader will have further analysis of their images. This is to look at the plaques in detail and to compare the sensitivity and specificity of the expert reader analysis. The time it takes for the clinician to report the scans on this group of patients will also be recorded. In addition, assessment will be made of the plaques using comparison of stenosis to calcium score.

.

Data that will be collected will include:

1. Demographic data (age, gender, ethnicity)
2. CCTA results - standard of care
3. CCTA results - Artrya Salix
4. Time from image upload to Artrya Salix to time report received from Artrya Salix
5. Time clinician takes to analyse scan
6. Clinical assessment of plaque for vulnerable characteristics.

The data will be from the electronic medical records of LNWUH NHS Trust. A level 2 or level 3 Cardiology imaging or Radiology Consultant will report the CCTA images.

Data will be captured on an eCRF. The time of image upload to Artrya Salix will be recorded by the system and transposed directly into the eCRF. The time starting and ending image analysis by the clinician will be recorded on a worksheet as source documentation and then entered into the eCRF. A score will be given by the physician as to the likelihood of a plaque being vulnerable where 1= unlikely and 5 = highly likely.

Eligibility Criteria:
Inclusion Criteria:

* Clinical CCTA
* Able to provide informed consent

Exclusion Criteria:

* Unable / unwilling to give informed consent
* Previous CABG or stent insertion