cyrilzakka/clinical-trials huggingface dataset:
Validation of Fenestrations Positioning by Numerical Simulation

Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks... The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

The goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at Vascutek and the one by numerical simulation performed by Predisurge company.

Eligibility Criteria:
Inclusion Criteria:

- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device

Exclusion Criteria:

* failure to generate an adequate FE model of patient arteries (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CT-scan slice thickness greater than 1mm, preoperative CT-scan with artifacts)
* stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
* patient refusing to participate to the study
Spatial Proteomics Profiles of Aldosterone-producing Adenoma and Unilateral Hyperplasia

Primary aldosteronism (PA) is a common cause of secondary hypertension, which is characterized by excessive aldosterone production by the adrenal gland. Excessive aldosterone can significantly increase the risk of cardiovascular disease and stroke. Patients with aldosterone-producing adenoma (APA) or unilateral hyperplasia (UAH) can be cured by unilateral adrenalectomy. The adrenal cortex is the outer part of the adrenal gland and is subdivided into three layers- the zona glomerulosa, the zona fasciculata, and the zona reticularis. And the outermost layer is the zona glomerulosa, and it's full of cells that make the hormone aldosterone. Although it has been investigated that the main cause of APA or UAH is the mutations of different calcium ion channels, including KCNJ5, CACNA1D, CLCN2 et al, it is still unknown whether there are any other changes of other proteins in different layers. Therefore, the investigators designed the study to characterize the proteomics profiles of adrenal adenoma/hyperplasia leading to primary aldosterone and identify biomarkers for early identification of PA by using spatial proteomics. The samples from adrenal adenoma or hyperplasia will be collected and analyzed by spatial proteomics in Hangzhou Jingjie Biotechnology Co., Ltd. The differentially expressed proteins in different layers will be screened out between APA and UAH, APA and its adjacent normal tissues, and UAH and its adjacent normal tissues, respectively. And KEGG analysis will be conducted to determine enriched pathway in these differentially expressed protein, respectively.


Eligibility Criteria:
Inclusion Criteria:

* According to the 2020 guidelines for primary aldosteronism, patients with positive primary aldosteronism confirmed test;
* Patients with predominant unilateral aldosterone secretion at AVS; adrenal CT suggesting unilateral adrenal adenoma (\> 0.8cm diameter) and no abnormalities in contralateral adrenal morphology.
* Patients who agreed to do the adrenalectomy.

Exclusion Criteria:

* adrenal CT suggests abnormal bilateral adrenal morphology or unilateral nodules.
* glucocorticoids can treat aldosteronism (GRA) and familial aldosteronism.
* other secondary hypertension: renal parenchymal hypertension, renal artery stenosis, Cushing syndrome, adrenal myeloid hyperplasia, aortic narrowing, obstructive sleep apnea hypoventilation syndrome.
* any other unsuitable condition for surgery.
* Patients who refused to perform adrenalectomy.
Regeneration of Bronchial Epithelium During Chronic Obstructive Pulmonary Disease

Airway epithelium integrity is essential to maintain its role of mechanical and functional barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial repair may participate in airway remodelling. The objective was to determine if airway epithelial wound repair of airway epithelium is abnormal in COPD.

Patients scheduled for lung resection were prospectively recruited. Demographic, clinical data and pulmonary function tests results were recorded. Emphysema was visually scored and histological remodelling features were noted. Primary bronchial epithelial cells (BEC) were extracted and cultured for wound closure assay. The investigators determined the mean speed of wound closure (MSWC) and cell proliferation index, matrix metalloprotease (MMP)-2, MMP-9 and cytokines levels in supernatants of BEC 18 hours after cell wounding. In a subset of patients, bronchiolar epithelial cells were also cultured for wound closure assay for MSWC analyze.

Eligibility Criteria:
Inclusion Criteria:

6 Patients scheduled for lung resection for cancer

Exclusion Criteria:

* Patients with asthma, cystic fibrosis, bronchiectasis or pulmonary fibrosis were excluded
A Clinical Randomized Controlled Trial of the New Method of Selective Coronary Vein Bypass Graft (SCVBG)

Apply a new operation method of Left Internal Mammary Artery (LIMA)-Greater Saphenous Vein (GSV)-SCVBG to the treatment of patients with diffuse coronary artery disease,through clinical randomized controlled study,compared with patients of bilateral internal mammary artery (BIMA)-SCVBG and evaluate both of therapeutic effects and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with right coronary artery diffuse lesions:Right coronary artery lumen≤1mm，Lesion lengths ≥20mm or multiple segment lesions.
* Patients of coronary artery bypass grafting (CABG) that can't be treated through endarterectomy.
* Patients ≤ 70 years old.
* All enrolled patients must being signed the informed consent.

Exclusion Criteria:

* Severe heart failure(ejection fraction under 35%) or non coronary atherosclerotic heart disease patients such as combined with severe valvular heart disease.
* Patients with acute myocardial infarction.
* Assistant examinations indicate that the bridge vessels can't be used；The left subclavian artery stenosis and/or LIMA lesions；RIMA lesions；varicosis of both great saphenous vein.
Gastric Emptying and Gallbladder Motility Study

Background of the study:

Plant sterols can play an important role in lowering plasma cholesterol. The extent to which plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest that the difference in these effects depends on gastric emptying and bile secretion.

Objective of the study:

The aim of this study is to gain insight in the mechanisms that may be involved in the effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test this, we compare the different effects of the consumption of a plant sterol containing drink prior to, during and after a standardized meal.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Sex: male
* Age: 18-55 years
* Body Mass Index (BMI): 20-25 kg/m2

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery which might limit participation in or completion of the study protocol.
* Use of any medication on regular basis.
* Use of paracetamol prior to treatment (≤ 48 hour).
* Use of plant sterol/stanol enriched products or supplements 3 months prior to the study.
* Blood donations less than three months previous to study enrolment.
* Known hypersensitivity or allergy towards paracetamol.
* Hyperlipidaemia (TG \> 3 mmol/L and/or tot. chol. \> 8 mmol/L)
* Corn products prior to treatment (≤ 48 hour)
* Presence of gallbladder stones.
* Known allergy for cow milk and/or lactose intolerance
REACH Hope Intervention for Dementia and TBI Caregivers

This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. The study will combine and deliver two award-winning behavioral interventions - REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box, which we call REACH Hope. Both REACH and Hope Box have evidence of effectiveness individually but have not been delivered together for caregivers supporting veterans with complex neurodegenerative diagnoses and health conditions. Our primary hypothesis is that REACH Hope will improve caregivers' quality of life as measured by reduced burden.


Eligibility Criteria:
Inclusion Criteria:

* primary caregiver for person with diagnosis of TBI and subsequent dementia
* at least one activity of daily living limitation or 2 or more instrumental activity of daily living limitation
* provide 4 or more hours of care per day for at least 6 months
* endorse a score of at least high burden (\>8) on the Zarit Burden Inventory-4

Exclusion Criteria:

* no mobile telephone or electronic device that can accept the Hope Box application
* current diagnosis of schizophrenia or other major mental illness
* auditory impairment that would make telephone use difficult
The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain

Non-specific chronic low back pain (LBP) can be managed with a variety of treatments such as educational programmes, behavioural therapy, acupuncture, medication, electrophysical agents, manual therapy and exercise therapy. Although the above therapies are widely used, they show limited effect at best, with frequent recurrences of LBP. There is insufficient data to prove that one type of exercise is superior to another. Manual therapy is a common therapeutic method used in the treatment of LBP. Therefore, we hypothesised that manual therapy combined with therapeutic exercises would lead to a greater reduction in back pain and improvement in functional status. The aim of the study was to evaluate the effect of 6 weeks of manual therapy combined with therapeutic exercise on pain and functional status in subjects with chronic non-specific low back pain.

The individuals with chronic non-specific low back pain participated in the study. Subjects were randomly divided into two groups: physiotherapy and manual therapy. All the participants received 12 intervention sessions. In addition, all subjects exercised at home 5 days a week. Subjects' back static strength endurance was assessed by the ITO test, abdominal muscle static strength endurance was assessed by the Kraus-Webber test, fear of movement by the TAMPA kinesiophobia test, torso mobility by the Schober test, pain by the numerical analogy scale. Functional status was assessed by Oswestry and Roland-Morris questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific low back pain (\>8 weeks);
* Persons of working age;
* Must be able to perform therapeutic exercises.

Exclusion Criteria:

* Severe cardiovascular disease;
* Oncological disorders;
* Neurological symptoms of disorders;
* Osteoarthritis;
* Spondylolisthesis and spondylosis;
* Radiculopathy;
* Myelopathy;
* Spinal fracture.
* Pregnancy or lactation.
Ultrasound-guided Precise Superficial Cervical Plexus Block

This prospective, randomized, observer-blinded study compared ultrasound-guided superficial cervical plexus block positioned by the great auricular nerve or conventional landmark technique.

Ultrasound guidance has become a reliable adjunct for brachial plexus, femoral, and sciatic nerve blocks. Furthermore, US can also be used to anesthetize purely sensory nerves such as the lateral femoral cutaneous and saphenous nerves. The superficial cervical plexus (SCP), a sensory neural plexus, supplies the skin overlying the ear, neck, angle of the mandible, shoulder, and clavicle. Traditionally, the SCP is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle. Unlike brachial plexus, sciatic nerve, etc., the SCP often cannot be displayed directly under ultrasound. The purpose of ultrasound guidance was to inject the local anesthetic solution into the correct intermuscular plane between the sternocleidomastoid and scalene muscles. In previous studies, the midpoint of the posterior border of the sternocleidomastoid muscle was often selected as the puncture point. Studies of ultrasound-guided superficial cervical plexus block are mostly unsatisfactory. Ultrasound guidance does not increase the success rate of SCP block compared with traditional technique.

The conventional landmark ultrasound guidance technique (LM group) selects the midpoint of the posterior border of the sternocleidomastoid muscle as the puncture point, but the anatomical difference of the individual cannot be considered. It may be the reason why ultrasound guidance cannot improve the success rate of the SCP block.

The great auricular nerve is the largest branch of the SCP and can be identified under ultrasound. This study intends to indirectly locate the SCP by ultrasound scanning of the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle (GAN Point). The method of precise SCP block at GAN Point under ultrasound guidance (GAN Group) was explored and compared with the LM Group.

Eligibility Criteria:
Inclusion Criteria:

* Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
* Patients undergoing neck and shoulder surgery

Exclusion Criteria:

* Communication barriers, unable to objectively describe symptoms
* Nerve block contraindicated
ESBL in Patients Returning to Sweden With Traveller's Diarrhoea

Patients with traveller's diarrhoea frequently harbour Extended Spectrum Betalactamase (ESBL)-producing Enterobacteriaceae (EPE) returning from EPE-endemic areas.

This study investigates to what extent travellers returning to Sweden with traveller's diarrhoea carry ESBL in their stool. The isolates are examined further according to species, phenotype, antibiogram and whole genome sequencing.

Samples sent to the department of clinical microbiology in Lund, Sweden for culture of salmonella, shigella, yersinia or campylobacter are also cultured selectively for ESBL.

All patients are contacted by mail with the results. ESBL-positive patients are invited to submit further faecal cultures and blood samples during one year follow up time, to investigate how long the patient is colonized with ESBL.

Eligibility Criteria:
Inclusion Criteria:

* Travellers diarrhoea
* foreign traveller

Exclusion Criteria:

* foreign traveller but no symptoms
Sirolimus Effect on Hypertrophic Syndromes Related Gene PIK3CA

It was found that people who have an excessive growth in one or more parts of their body and normal growth in other parts, may have a change in genes responsible for controlling cell growth. This genetic discovery identified a possible treatment for this overgrowth, called Sirolimus.

This is a pilot study, which help the investigators prepare a larger international study, which will aim to determine whether a treatment based Sirolimus is able to stop the excessive growth of one or more parties of their body in people who carry a genetic change in the PIK3CA gene (phosphatidylinosilol-3-kinase encoded by the gene PIK3CA).

The duration of participation is 15 months:

* Visit screening: blood test, pre-clinical evaluation, urine collection and chest X-ray.
* First 6 months: participants will have their overgrowth monitored. This step includes 2 visits taking place at the University Hospital of Dijon: complete clinical evaluation, MRI of the body part by the overgrowth and Dual-energy X-ray absorptiometry (DXA).
* Next 6 months: participants will take Sirolimus. This step includes 2 visits (4 and 13 weeks after the start of treatment at local hospital): blood test, urine collection and clinical evaluation.

and 1 end of study visit after 6 months of treatment taking place at the University Hospital of Dijon: blood test, complete clinical evaluation, urine collection, MRI and DXA.

Participants will have several blood and urine tests between visits (1 and 2 weeks after the start of treatment at a local laboratory).

Eligibility Criteria:
Inclusion Criteria:

* Post-zygotic PIK3CA mutation
* Age: 3-65 years
* Measurable overgrowth, in current progression or with clinical history of overgrowth progression
* Patient clinically stable
* Presence of a disability, social or cosmetic impairment requiring treatment from the patient perspective,
* Written informed consent form signed and dated by the subject or by the patient's legal representative

Exclusion Criteria:

* Pregnancy or lactation
* Women and men of reproductive age without any effective method of contraception (during treatment and up to 12 weeks after sirolimus discontinuation)
* Hypersensitivity to the active substance (sirolimus) or to any of the excipients
* Impossibility to obtain written informed consent form signed by the subject or the patient's legal representative, or vulnerable adults
* Treatment with Sirolimus in the last 4 weeks before the trial
* Personal history of malignancy or current investigations for suspected malignancy
* Active skin infection requiring antibiotics or antiviral treatments
* HIV or hepatitis B or C infection
* Past history of Mycobacterium tuberculosis infection
* Active pneumopathy
* Uncontrolled infection
* Chronic liver disease (ASAT or Alanine amino transférase (ALAT)\> 3 times upper normal limit)
* Stage 3 (or more) chronic renal insufficiency (eGFR\< 60mls/min)
* Neutropenia with neutrophiles \< 1.0 x10\^9/L
* Uncontrolled dyslipidemia
* Inability to attend study visits
Comparison of the DANA to the ANAM in the Evaluation of Cognitive Changes After Concussion

The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable, portable, and "field-hardened" NeuroCognitive Assessment Tool. The purpose of this study is to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological Assessment Metrics (ANAM) battery currently used by the military after concussion. The primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued impaired cognitive performance than the ANAM during recovery after a concussion.

Among active duty military personnel deployed to combat theaters, blast injury is a leading cause of traumatic brain injury (TBI). Service members with TBI can experience notable neurological impairments-e.g., attention disturbances, memory and language deficits, and delayed reaction time. Cognitive performance can still be impaired 2-4 weeks after concussion with no overt physical symptoms. Thus, there is a critical need to have an efficient means to determine the incidence of cognitive deficits in service members exposed to or injured by blasts. To that end, this study plans to evaluate the ANAM and the DANA to determine which neurocognitive test more reliably and accurately detects cognitive impairments during the recovery period from a concussion.

Eligibility Criteria:
Inclusion Criteria:

* Active-duty U.S. military service members
* Clinical diagnosis of concussion/mild traumatic brain injury (mTBI) (as defined by the American Congress of Rehabilitation, 1993, and DoD), made by the treating clinician based on clinical history, examination and/or clinical imaging performed as part of standard of care. This includes subjects with concussion from any mechanism (blast-related, blunt trauma etc.)--for concussed subjects only
* Glasgow Coma Scale (GCS) score of 15 as assessed by the consenting research staff--for concussed subjects only
* Concussive event that occurred within 72 hours of injury (to exclude service members presenting due to lingering effects of a previous injury)--for concussed subjects only
* Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent.

Exclusion Criteria:

* Have a history of other mTBI within 90 days, moderate brain injury within the past 3 years, or any lifetime history of severe brain injury
* History of a documented diagnosis of post traumatic stress disorder (PTSD) or of treatment for PTSD
* Taking psychoactive medications, opioids, or other significant sedating medication
* Individuals with severe psychiatric disorders requiring continuing medication or recent treatment for an alcohol or drug dependency
* Report a pain level of 8 or greater on the 10-point Likert scale of 1 to 10 (e.g., 8, 9 or 10).
EMR Data to Assess Monitoring of Patients Treated With Quetiapine

A study to evaluate the effectiveness of an update of educational materials with respect to evaluation of monitoring of metabolic parameters

Objective assessment of metabolic monitoring in patients treated with Seroquel® or Seroquel® XR/quetiapine fumarate: use of IMS Disease Analyzer to assess physician behaviour in the UK and Germany

Eligibility Criteria:
Inclusion Criteria:

- Electronic medical records of patients with diagnoses of schizophrenia, Bipolar Disorder (BPD) or Major Depressive Disorder (MDD) treated with Seroquel® or Seroquel®XR during the calendar periods: 13 Feb - 31 Aug 2012 seen by GP \& psychiatrists in Germany \& 11 Jan-31 July 2012 seen by GPs in the UK

Exclusion Criteria:

- Patients with above mentioned diagnoses treated with Seroquel® or Seroquel® XR/quetiapine fumarate not having any medical encounters during the time periods: 13 Feb - 31 Aug 2012 in Germany \& 11 Jan-31 July 2012 by GPs in the UK