cyrilzakka/clinical-trials huggingface dataset:
Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.

Microcirculatory changes during cardiac surgery have been investigated mainly during coronary procedures using the conventional extracorporeal circulation.There is no single study in the literature investigating microcirculatory alterations using a perioperative strategy of "physiologic" perfusion.

Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

All patients will follow the same anaesthetic and perfusion protocol. The patients will be randomized to two arms:

1. Patients operated with Minimal Invasive Extracorporeal Circulation (MiECC)
2. Patients operated with conventional cardiopulmonary bypass (cCPB)

The protocol for the evaluation of microcirculation will be based on:

* Cerebral near-infrared spectroscopy (rScO2) measurements (INVOS, Covidien-Medtronic Inc.).
* NIRS-Based Cerebral Autoregulation Monitoring: Analog arterial blood pressure signals will be digitized and then processed with the digital NIRS signals using a personal computer and a special ICM software (University of Cambridge, Cambridge, UK). Monitoring cerebral autoregulation ensures adequate renal perfusion. Hence, brain can be used not just as a target but also as an index organ indicating adequacy of perfusion.
* Somatic near-infrared spectroscopy (rSsO2) measurements (INVOS, Covidien-Medtronic Inc.).
* Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging (MicroScan, Microvision Medical, Amsterdam, The Netherlands).

All measurements will be performed at the following time points:

T0: after induction of anaesthesia T1: after initiation of cardiopulmonary bypass T2: 10 minutes after cross- clamping the aorta T3: 10 minutes before removing the aortic cross-clamp T4: after weaning from extracorporeal circulation

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation

Exclusion Criteria:

* patients undergoing emergency surgery
* patients in preoperative cardiogenic shock with evidence of tissue malperfusion
* patients with severe peripheral vascular disease
* patients unable to give informed consent
Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma

Highly active hepatitis B virus (HBV) is known to be associated with poor outcomes in patients with hepatocellular carcinoma (HCC). This study aims to investigate the relationship between HBV status and HCC recurrence after liver transplantation. The study retrospectively analyzed HCC patients undergoing liver transplantation in 2 centers between January 2015 and December 2020. We reviewed post-transplant HBV status and its association with outcomes.


Eligibility Criteria:
Inclusion Criteria:

* (1) preoperative diagnosis of HBV-related HCC and (2) pathologically confirmed HCC.

Exclusion criteria

* (1) non-HBV-related HCC; (2) simultaneous presence of other tumors; (3) re-transplantation; (4) presence of portal vein tumor thrombus; and (5) a survival time of less than 90 days.
The Effect of Whole Body Vibration Training on Neuromuscular Property in Individuals With Ataxia

The Cerebellum contains ten percent of the total volume of the brain and receives brain, spinal cord and vestibular sensory input. The organization of vestibular and somato-sensory afferent informations are also reported to be impaired in patients with cerebellum dysfunctions. Ataxia and impaired balance control are common symptoms in individuals with spinocerebellar ataxia (SCA). Previous studies have shown that patient with cerebellar damage are usually agonist and antagonist muscle coordination problem. Past studies also found the regulation of reciprocal Ia inhibition was impaired in patients with spinaocerebellar ataxia. In chronic phase, weakness might be developed due to deconditioned. All deficits mentioned above might lead to a decrease functional ability. Therefore, increasing somato-sensory and vestibular input, normalizing the modulation of recriprocal inhibition, and improve muscle strength might be able to improve the functional abilities of individuals with SCA.

Recently, whole body vibration (WBV) has been trained for health groups. Studies showed that WBV training were able to improve muscle strength, balance control, and functional ability. However, there is no evidence showed that whether the whole body vibration training can affect the brain and spinal cord for the regulation of neural circuits. Whether also can affect for maximal voluntary contraction and improve central fatigue. No previous studies that whole body vibration training for SCA.

Therefore, the purpose of this research was to investigate the intracortical facilitation and inhibition, reciprocal Ia inhibition, low frequency depression, maximal voluntary contraction, interpolated twitch technique to compare the different between the SCA and health subject. Also to investigate the short term and long term effect of WBV.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of spinocerebellar ataxia
Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This would lead to a decrease in incidence, mortality and health care costs associated to this syndrome.

This study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.

The main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ARDS development.

Eligibility Criteria:
Inclusion Criteria:

* Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).
* LIPS \> 4 points.
* Absence of mild, moderate and severe ARDS criteria (Berlin definition).
* Older than 18 year-old.
* Signed informed consent

Exclusion Criteria:

* Bilateral pulmonary infiltrates in chest X-ray at admission.
* Mechanical ventilation \> 12 hours.
* Previous pneumonectomy or lobectomy.
* Severe cranial trauma (Glasgow Coma Scale\<9) or cranial hypertension.
* Severe chronic pulmonary disease (GOLD IV).
* Admission from other hospital under MV.
* Limitation of therapeutic effort.
* Pregnancy.
* Acute pulmonary embolism.
* Participation in other interventional trials.
* Previous randomized in the proposed trial.
* Absence of informed consent.
9 Minutes for Colonoscopy Withdrawal

A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose age is between 40-85.
* Patients who have indications for screening, surveillance and diagnostic colonoscopy.
* Patients who have signed inform consent form

Exclusion Criteria:

* Patients who have undergone colonic resection
* Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
* Patients with severe chronic cardiopulmonary and renal disease.
* Patients who are unwilling or unable to consent.
* Patients who are not suitable for colonoscopy
* Patients who received urgent or therapeutic colonoscopy
* Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
* Patients who are taking aspirin, clopidogrel or other anticoagulants
* Patients with Aronchick score \> 3
Description of Statics by EOS Imaging and Evaluation of the Efficacy of Intradiscal Corticosteroid Infiltration

Inflammatory disc disease or Modic 1 disc disease is a radiological entity first described by Modic in 1988 and corresponds to an inflammatory signal on MRI defined by the presence of a T2-weighted hypersignal and a T1-weighted hyposignal of the vertebral endplates adjacent to a pathological disc.

The presence of these radiological abnormalities are significantly associated with chronic low back pain, the therapeutic management of which may include lumbar rehabilitation, rigid corset, spinal infiltrations and surgical treatment. Corticosteroid infiltration of the pathological intervertebral disc (intradiscal infiltration) has been evaluated in low back pain due to Modic 1 disc disease with short-term efficacy. The clinical response to this infiltration is not always optimal and to date in the literature, no predictive factor of response has been identified.

There are several hypotheses to explain this phenomenon: mechanical, genetic, infectious or inflammatory. One of the mechanical hypotheses would be the presence of an instability of the spinal segment (hypermobility of the spinal segment) and disorders of the sagittal statics of the spine with angles of thoracic kyphosis and lumbar lordosis weak and a weak sacral slope supporting a hyperpressure passing by the discs and the genesis of discopathy.

In this work, the investigators will evaluate the different parameters of the spinal statics in the sagittal plane and in the frontal plane (sacral slope, pelvic version, Roussouly classification, cobb angle...) by EOS imaging as well as the parameters of the Modic 1 anomaly on lumbar MRI (spinal stage, Pfirmann classification, laterality of the inflammatory signal) in a population of patients who received intradiscal corticosteroid infiltration for low back pain in the context of Modic 1 disc disease.

The analysis of the different radiological parameters could enrich the investigator's understanding of the pathophysiology and evaluate radiological factors predictive of the effectiveness of intradiscal infiltration in this population. This could allow us to adapt the management of low back pain patients with Modic 1 disc disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* French speaking patient
* Patient hospitalized in the rheumatology department of GHPSJ between 01/01/2014 and 31/12/2020 for MODIC 1
* Patients who received as part of their management an intra-disc infiltration with hydrocortancyl.

Exclusion Criteria:

* Patient under guardianship or curators
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his data for this research
* Patient having benefited from another infiltration between the intradiscal infiltration and the collection of efficacy data at 3 months.
Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles

The objective of this clinical study is to evaluate the efficacy of fractional RF for the treatment and reduction of acne scarring or facial wrinkles.

Prospective, single centre, evaluator-blind, split face study of the efficacy of fractional radiofrequency (RF) for the treatment and reduction of acne scarring and facial wrinkles. The study will evaluate the progress of 15 subjects requesting treatment of scarring or facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or wrinkles.
2. Able to read, understand and voluntarily provide written Informed Consent.
3. Able and willing to comply with the treatment/follow-up schedule and requirements.
4. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.

Exclusion Criteria:

1. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
2. Subjects with any implantable metal device in the treatment area
3. Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
4. Current or history of any kind of cancer, or dysplastic nevi
5. Severe concurrent conditions, such as cardiac disorders.
6. Pregnancy or intending to become pregnant during the study and nursing.
7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
9. Poorly controlled endocrine disorders, such as diabetes.
10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
12. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
13. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
14. Use of isotretinoin (Accutane®) or other systemic retinoids within six months prior to treatment or as per investigators discretion.
15. Any surgical procedure in the treatment area within the last six months or before complete healing.
16. Treating over tattoo or permanent makeup.
17. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
Efficacy of Penile Traction Therapy Using a Novel Device

This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to Peyronie's disease, a condition which results in penile curvature and length loss. The trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. Final assessments for adverse effects will also be assessed at 9 months.

Peyronie's disease (PD) is a fibrotic condition of the penis, affecting 1-13% of the US male population. The disease results in penile curvature and significant psychosocial bother. Current preferred therapies for PD include repeated penile injections with bacterial enzymes and surgery. However, these therapies are expensive and in some cases result in permanent reductions in penile length and sensation. Penile traction therapy (PTT) is a relatively newer treatment which has been proposed as a treatment for PD with preliminary data suggesting a potential role. However, currently available PTT devices are primarily designed for penile lengthening and have many significant limitations including a requirement of use for 9 hours daily and significant difficulties in personal application. Given these limitations, a new penile traction device (RestoreX® ) was created and funded through Mayo Ventures and was specifically designed to treat men with PD. The primary objective of the current study is to evaluate safety of the device using various dosing schedules, with secondary endpoints designed to assess efficacy and subjective outcomes. To accomplish the study, a population of men from Mayo Clinic with PD will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 3, 6, and 9 months, and results are to be used with the intent to publish in a scientific journal.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Peyronie's disease
* Current 30 degree curvature in a single plane (i.e. 20 degrees up, 15 degrees left would not be a candidate)
* Not undergoing other therapies for PD currently

Exclusion Criteria:

* Stretched penile length \<7 cm
* Prisoners
* Erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies
* Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)
Renal Denervation in Treatment Resistant Hypertension

In patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.

The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:

Short term effects:

A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation

Long term effects:

D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall properties after 6 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* treatment resistant hypertension
* male of female aged over 18 years
* written informed consent
* agreement to attend all study visits as planned in the protocol

Exclusion Criteria:

* chronic kidney disease 3 - 5
* any contradictions for MRI
* claustrophobia
* strabismus
* severe ocular diseases
* history of epilepsia
Baduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems

Females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly

Females (forty in number) with sub-clinical hypothyroidism exhibit cognitive problems, they are elderly, will be divided to exercised group (baduanjin training will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20) and other non exercised group (number of patients will be 20) . all women of groups will received their prescribed daily one-dose medication tablet (levothyroxine).

Eligibility Criteria:
Inclusion Criteria:

* female with sub-clinical hypothyroidism
* females with mild cognitive impairment
* females with obesity (obesity class one)

Exclusion Criteria:

* neurological problems
* orthopedic problems
Local IgE in Subjects With Allergic or Non-allergic Rhinitis

The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not selected group of young students (n=100-300). Students will be selected by public posting. In all students an allergy skin test will be performed. Then the local IgE of 24 subjects with non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic rhinitis and positive prick test to house dust mite. In addition 20 controlls will be investigated. Based on these investigations, the importance of local IgE and the IgE spectrum in conjunction with rhinitis should be further clarified.

20% of Germans suffer from seasonal or all-season rhinitis. Despite typical allergic symptoms, in a part of the affected patients (about 10-20%) an allergy cannot be found on skin prick test or blood. Therefore, the planned trial will investigate the incidence of allergic and non-allergic rhinitis in a non selected group of young students (n=100-300). The hypothesis postulates that in test subjects with non-allergic rhinitis the allergy can only be proven locally in nasal secretion.

From the initial large cohort of patients, 24 subjects with house dust mite allergy and allergic rhinitis and 24 patients with non-allergic rhinitis will be selected and investigated in more detail at a second visit. At the second visit, blood and nasal secretion (measurement of local IgE) will be taken from all pre-selected 48 patients. At visit 2 a nasal provocation test with house dust mite allergen will be performed in all patients to compare nasal symptoms with the results of local IgE between patient groups. In addition the same investigations will be performed in a group of 20 healthy non-allergic subjects.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Seasonal or all-season symptoms of an allergic or non-allergic rhinitis
* Healthy non-allergic subjects

Exclusion Criteria:

* Patients: Age \<18 and \> 45
* Other severe diseases (e.g. Cystic fibrosis, diseases with immunosuppression, malignant diseases)
* Previously occurred allergic shock
* Pregnancy and lactation
* Participation in another clinical trial within the last 30 days
* Inability to measure the length and the consequences of the study
* Frequent use of medication which could not be discontinued in the defined time before enrollment: nasal vasoconstrictors 1 day; antihistamines 3 days; nasal steroids 7 days; oral cortison 4 weeks; leukotriene antagonists and cromolyn 2 days before NPT