cyrilzakka/clinical-trials huggingface dataset:
Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment

The aim of the current study is to evaluate the association of fatty liver severity and endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the impact of statin treatment compared to usual care or life style modification on endothelial function, liver steatosis and fibrosis.

The study cohort will include 150 patients with fatty liver per ultrasound or histology. The patients will be divided randomly to one of three arms: follow up group, lifestyle modification group, and statins therapy (Atorvastatin 20mg/d for 6 months). at screening, after 6 months (end of treatment), and 12 months the patients will undergo:

1. complete physical examination
2. blood pressure measurement
3. assessment of height and weight, body mass index and waist circumference
4. blood samples for complete blood count, fasting plasma glucose, fasting plasma insulin, lipid profile, liver enzymes, albumin, bilirubin, Prothrombin time (PT INR), Hemoglobin A1c, ferritin, adiponectin, C-reactive protein, Tumor necrosis factor alpha, Lipoprotein-phospholipase A2, Apolipoproteins B100, A1, C3, C4, ceruloplasmin
5. Liver elastography and sonographic liver fat quantification
6. Brachial artery flow-mediated dilatation (FMD) measurement

Eligibility Criteria:
Inclusion Criteria:

* subjects willing to comply with study requirements and have signed an informed consent form
* fatty liver per abdominal ultrasound or liver biopsy

Exclusion Criteria:

* alcohol drinking \>140g/week
* presence of hepatitis B or C or HIV
* known liver disease other than fatty liver
* usage of drugs known to cause liver steatosis
* subjects with known allergies or hypersensitivity to statins
* subjects with known cardiovascular/cerebrovascular disease
* subjects with known dyslipidemia requiring drug treatment
* subjects with diabetes mellitus
* history of drug or alcohol abuse
* refusal to sig the informed consent form
Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder

Major depressive disorder (MDD) is a prevalent mental illness characterised by influencing the health and quality of life of patients，often manifesting in individuals under the age of 18. It has been wildly confirmed that acupuncture alone or in combination with the applicable adjuvant therapy for MDD can not only relieve patients' physical symptoms, but also enhance sleep quality. Intradermal acupuncture, as an acceptable and long-lasting treatment modality, is the focus of this research. This study was conducted to investigate the efficacy of intradermal acupuncture in the treatment of MDD.

This study will enroll a total of 120 adolescents with MDD who meet the inclusion criteria. Participants will be randomly assigned 1:1:1 to the waiting list group (patients in this group will be treated with selective 5-hydroxytryptamine reuptake inhibitors (SSRIs) only), sham intradermal acupuncture combined with SSRIs (SIA) group and active intradermal acupuncture combined with SSRIs (AIA) group. The study is aim to evaluate the efficacy of intradermal acupuncture for MDD and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); HAMD-17≥7
2. Aged between 12 and 17 years (no limitation on gender);
3. Take SSRI for at least two weeks;
4. Written informed consent is obtained by the person or guardian.

Exclusion Criteria:

1. ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction;
2. Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system;
3. Acute suicidal tendency;
4. Allergy to adhesive tape and fear of intradermal acupuncture;
5. Pregnancy and lactation;
6. Mental retardation and difficult to cooperate with doctors.
7. Participating in other clinical trials.
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain

The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with painful symptoms due to neuropathic pain
* Provision of signed informed consent
* Non pregnant females

Exclusion Criteria:

* Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
* History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator
Psychological Impact of COVID-19 Quarantine and Worsening of Cardiovascular Risk in the French General Population

In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.

In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.

A prospective epidemiological observational cohort study will be carried out (in French general population aged 50 to 89 years) with data collection by telephone interviews (in agreement with the context of quarantine).

The telephone interviews will be carried out during quarantine (V1), in the month following the end of quarantine (V2) and then, at 6 (V3) and 12 (V4) months. At baseline, the questionnaire will focus on socio-demographic and contextual characteristics related to the COVID-19 outbreak, medical history, cardiovascular risk factors and treatments, anxiety and depression scales. Next (after the quarantine), the questionnaire will focus on the evolution of cardiovascular risk factors and the occurrence of acute cardiovascular events, the evolution of treatments and post-traumatic stress, anxiety or depression scales.

The assessment of risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors of the worsening of cardiovascular risk will be based on mixed logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* All participants of the MONALISA survey residing in south-western France (Toulouse area).

Exclusion Criteria:

* Opposition to participate in this new survey
* Pregnancy or breastfeeding
* Subject under guardianship, curatorship or safeguard of justice
* Lack of health insurance coverage
FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study

Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).

Up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-ST elevation acute coronay syndromes or stable angina pectoris will be included in the Netherlands and Belgium.

Device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Stable angina, unstable angina or documented silent ischemia (invasive or non-invasive test) or non-ST segment elevation acute myocardial infarction.
* De-novo non-complex coronary obstructive lesions (\>50% stenosis as assessed by quantitative coronary analysis (QCA))
* The patient is willing and able to comply with the specified follow-up evaluations.
* Reference vessel diameter (RVD) ≥ 2.5 mm and ≤ 4.0 mm by QCA.
* During pre-dilatation, the pre-dilatation balloon is uniformly expanded to the full intended diameter.
* Target segment suitable for OCT imaging

Exclusion Criteria:

* Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1.
* Target lesion located within 5.0 mm of vessel origin.
* Lesion type ACC/AHA C.
* Heavily calcified lesion
* Severe tortuosity
* Target lesion is located in or supplied by an arterial or venous bypass graft.
* Target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
* Unsuccessful pre-dilatation, defined as a residual diameter stenosis ≥ 30%, assessed by QCA.
* Planned future revascularization of non-culprit lesions.
* Presence of another device (stent or scaffold) located within the same segment (5mm from the target lesion borders).
* Patient is currently participating in another study with an investigational device or an investigational drug and has not completed the entire follow-up period.
* Impaired renal function (eGFR \<30ml/min).
* Patient has a contraindication for the use of double antiplatelet therapy for at least 12 months.
* Pregnant or breastfeeding patients.
* Patient has a known allergy to contrast medium, sirolimus, Tyrosine-derived polycarbonate or other structurally related compounds.
* Patient is receiving chronic oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (diabetes mellitus is not an exclusion criteria).
* Patient has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.
The Effects of Treadmill Versus Agility Training in Parkinson's Disease

Aim:

To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used to quantify balance and gait performance before and after two PT-supervised, intensive, exercise programs, expected to improve balance and gait. The first program is a published Treadmill training program and the second is the investigators new Agility training program with sensorimotor progressions, targeted at specific impairments that underlie the abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in preparation for a larger clinical trial to determine the most effective exercise for mobility disability in PD. The effects of exercise will be compared with no treatment during a 5-week delay prior to start of exercise.

This trial will also determine the relative responsiveness (compared to traditional clinical scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to show there is a difference between the exercise groups. Superior responsiveness of the iMOBILITY system will be determined by larger differences with exercise intervention with the iMOBILITY system than with traditional clinical measures of mobility in PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic PD

Exclusion Criteria:

* Other neurological conditions, artificial joints
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol

Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment can be surgical or conservative using vaginal pessaries. These devices are introduced into the vagina aiming to reduces the prolapse.

Pessaries have shown effectiveness in improving symptoms and quality of life. There are no randomized studies comparing them with surgery. This study design would be difficult to perform, because the inclusion criteria for both treatments are different. There are no currently standard protocols for the use of pessaries. This makes harder to widespread the usage of this conservative treatment.

The aim of the investigators is to identify variables that influence the success of conservative management of genital prolapse at 1 year of follow up. Using these variables and an expert panel opinion the investigators will develop a standardized protocol for pessary management.

Chile has a primary gynecological care system based midwives. Therefore having algorithms for pessaries usage becomes relevant. This algorithm can be implemented with basic training. This would increase the respond capacity, by the health care system to this disease, considering the scarce access to surgery.

The investigators hypothesis is: It is possible to generate a standardized protocol of conservative management of symptomatic genital prolapse in patient's beneficiary of public health system in Santiago, Chile, using pessaries through a prospective cohort study based in the success of these devices with 1 year of follow up, measured with questionnaires of symptoms, quality of life and sexuality


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Pelvic Organ Prolapse
* Commitment to attend controls
* Current negative cervical cytology
* Informed consent signed

Exclusion Criteria:

* Urinary incontinence as the only Pessary Indication
* Vaginal bleeding of undetermined cause
* Unable to return to controls
Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness

Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able to predict fluid responsiveness in surgical or critically ill patients. Their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system by position change. The aim of this prospective trial is to investigate the ability of stroke volume variation and pleth variability index to predict fluid responsiveness in the reverse trendelenberg position.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20
2. elective robot assisted thyroidectomy

Exclusion Criteria:

1. arrhythmia
2. BMI\>30
3. valvular heart disease
4. pul hypertension
5. peripheral artery occlusive disease
6. lung disease
7. right heart failure
The Effects of a Combined Exercise Training Program on Vascular Health and Metabolic Profile in Obese Adolescent Girls.

The purpose of this study was to examine the impact of 12 weeks of combined exercise training (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance, and body composition in obese adolescent girls. Thirty obese adolescent girls participated in this study. The girls were randomly divided into CET group (n=15) and control group (n=15). The CET group performed concurrent resistance training followed by aerobic training at 40-70% of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1, C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio were measured before and after the 12-weeks study.


Eligibility Criteria:
Inclusion Criteria:

* Obese with hyperinsulinemia
* Abdominal obesity
* Sedentary (no regular exercise training or physical activity)
* No weight loss diet during last 6 months.

Exclusion Criteria:

* Hypertension
* Pregnancy
* Chronic disease
Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin

The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with intestinal colonization by Klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by Klebsiella pneumoniae:
* Surgery in two weeks
* Transplant in two weeks
* Require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia)
* Recurrent or severe infections
* Institution admission
* Fragile patients at high risk of readmission.

Exclusion Criteria:

* The presence of an active infection for Klebsiella Pneumoniae.
* Concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.
Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo

Our data indicate that the CFTR-molecule functions as a transporter for sphingosine-1-phosphate and sphingosine or regulates the uptake of these sphingolipids by epithelial cells. The disturbed uptake of sphingosine and sphingosine-1-phosphate over the cell membrane results in an accumulation of ceramide in the cell membrane, which finally triggers a pro-inflammatory and pro-apoptotic status in the respiratory tract of cystic fibrosis patients. Amitriptyline reduces the cera-mide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells observed in CFTR-deficient mice. Most important, amitriptyline prevents pulmonary infections of CFTR-deficient mice with P. aeruginosa. These effects of amitriptyline may result in an improved lung function of cystic fibrosis patients.

Cystic fibrosis (CF), the most common autosomal recessive disorder at least in western countries, is caused by mutations of the cystic fibrosis transmembrane conductance regulator molecule (CFTR) and affects approximately 40 000 patients in Europe. Most, if not all, CF-patients develop a chronic pulmonary infection with Pseudomonas aeruginosa (P. aeruginosa). At present it is un-known why CF-patients are highly sensitive to P. aeruginosa infections and, most important, no curative treatment for cystic fibrosis is available.

Our data on CFTR-deficient mice demonstrate that the CFTR-molecule does not only function as a chloride-channel, but also as a transporter for sphingolipids, in particular sphingosine and sphingosine-1-phosphate. Deficiency of functional CFTR in CFTR-knock-out mice results in an alteration of the sphingolipid metabolism in pulmonary epithelial cells and an accumulation of cellular ceramide in these cells.

Inhibition of ceramide release in the lung was achieved by pharmacological and genetic inhibition of the acid sphingomyelinase (ASM) that generates ceramide from sphingomyelin. Amitriptyline was employed to pharmacologically block the ASM genetic inhibition of the ASM was achieved by crossing CFTR- and ASM-deficient mice. Although the ASM is not affected in cystic fibrosis, an inhibition of the enzyme should block the formation of ceramide and, thus, normalize the increase of pulmonary ceramide caused by CFTR-deficiency.

Eligibility Criteria:
Inclusion Criteria:

1. Cystic Fibrosis is proved
2. The patient are older than 18 years (\<50 years)
3. No sec discrimination
4. The patient is pulmonal colonized with bacteria
5. Signs of pulmonary exacerbation are not present
6. A full course of therapy is possible without any restrictions
7. Lung function measurement is possible

Exclusion Criteria:

1. Poor metabolizer for amitriptyline (CYP2D6 genotyping)
2. Glaucoma, seizures, heart insufficiency or depression is present
3. Signs of acute pulmonary illness (bronchial or tracheal stenosis, tuberculosis, thorax trauma, acute pneumonia, pneumothorax, bronchial haemorrhage, ARDS) are present
4. intravenous antibiotic treatment was necessary in the last 4 weeks
5. Involvement of the patient in another study
6. Pregnancy
Cervical Pain and Exercise in Musicians

Exercise training that is one of the effective treatment methods for cervical pain, is crucial in developing mobility and stability. Exercise training significantly reduces cervical pain as it advances postural alignment and neuromuscular coordination. In many single group studies on cervical pain in violin performers, it has been reported that the stabilization exercises have favorable consequences on pain relief and postural correction. But, there are no studies comparing ney and violin performers and analyzing the effectiveness of exercise training on non-specific cervical pain. The aim of this study is to search the effects of selected exercise training on pain, disability, range of motion, flexibility, strength and quality of life in ney and violin performers with non-specific cervical pain.


Eligibility Criteria:
Inclusion Criteria:

* Being professional musicians
* Using violin or ney musical instruments
* Had non-specific cervical pain during 3 months

Exclusion Criteria:

* Had cervical surgery in the last 3 months, discogenic pain, radiculopathy, neurological or systemic disorders,
* Missing exercise training session more than 2
Comparison of Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal Cancer

Numerous comparison studies on the outcomes of robotic and laparoscopic surgery in the treatment of rectal cancer have been undertaken and reported. But there aren't many studies that compare the safety and effectiveness of the two surgery procedures used to treat people with mid and low rectal cancer who have different body mass indexes (BMIs). This study was done to organize the clinical data we had at our hospital so we could compare the perioperative effectiveness of two minimally invasive approaches for people with different BMIs.


Eligibility Criteria:
Inclusion Criteria:

The inclusion decision was made based on the following criteria: the results of the preoperative evaluation revealed the existence of adenocarcinoma in the middle to lower rectum (less than 10 centimeters distant from the anal edge); received a drastic operation that might have been laparoscopic or robotic and was based on the principle of TME; distant metastases that are non-conformist or heteroclinic, and there are no additional malignant tumors present at the same time as the operation.

Exclusion Criteria:

a high tumor location that was more than 10 centimeters away from the anal margin; surgery was unsuccessful in completing anal preservation due to invasion of the external anal sphincter; cancerous obstruction or perforation; severe cardiopulmonary dysfunction classified as stage IV according to the ASA score; and poor preoperative anal function; any resection that is performed in combination, rather than being a R0 resection.