cyrilzakka/clinical-trials huggingface dataset:
Association Between Left Ventricular Deformation and Aerobic Exercise Capacity in Untreated Arterial Hypertension

Impaired myocardial deformation may determine cardiac diastolic dysfunction. The investigators will investigate the vascular determinants of myocardial deformation and twisting-untwisting and their interrelation with exercise capacity in patients with untreated arterial hypertension

The investigators plan to examine 320 untreated hypertensives and 160 controls. They will measure:

1. the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
2. the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg x kg-1 x min-1) by Doppler echocardiography
3. the Global Longitudinal strain and strain rate, peak twisting, the percentage changes between peak twisting and untwisting at mitral valve opening (UtwMVO), at peak (UtwPEF) and end of early LV diastolic filling (UtwEDF) by speckle tracking imaging
4. the perfusion boundary region (PBR-micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glycocalyx thickness
5. transforming growth factor (TGFb-1), metalloproteinase-9 (MMP-9), markers of collagen synthesis (N-terminal procollagen type-III propeptide , carboxy-terminal propeptide and telopeptide of procollagen type-1, representing cardiac extracellular matrix turnover) and N-terminal pro-brain natriuretic peptide (NT-proBNP) and soluble angiotensin-converting enzyme (sACE).
6. Twenty-four hour daytime and night-time average systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rates as well as 24h-pulse pressure (PP) by means of 24h ambulatory blood pressure monitoring (ABPM) Monitoring will be carried out on the non-dominant arm using the valid recorder TONOPORT V (General Electric, Health Care, Berlin, Germany) after validation of readings against a mercury sphygmomanometer by means of a Y tube. The ABPM device will set to obtain BP readings at 15 min intervals during the day (07.00-23.00) and at 20 min intervals during the night (23.00-07.00). The patients will be instructed to attend their usual day-to-day activities but to keep still at the times of measurements. Recordings will be analysed to obtain
7. oxygen consumption as an absolute value and in relation to body weight (VO2/Kg) and maximum work load (METS) by means of a physician-supervised maximal, symptom-limited cardiopulmonary exercise test (CPET) on a bicycle ergometer using a standard ramping protocol (Oxycon Pro system, Jaeger, Germany).

Eligibility Criteria:
Inclusion Criteria:

* untreated patients with newly diagnosed essential hypertension
* normotensive subjects

Exclusion Criteria:

* history of diabetes
* familiar hyperlipidemia
* coronary CAD
* cardiomyopathy
* chronic pulmonary disease
Aspergillosis and Humoral Alveolar Immunity by Proteomics

Aspergillus fumigatus is the most common opportunistic mold found in lung fungal infections in humans. Aspergillus is the cause of invasive pulmonary aspergillosis with a poor prognosis in immunocompromised patients and the chronic pulmonary aspergillosis which affects 3 million patients worldwide, with underlying pulmonary pathologies such as tuberculosis and its sequelae. The medicinal means to fight against these different forms are limited and not very effective. In addition, the emergence of resistance makes the search for new therapeutic strategies of major importance.

The interaction between the fungal spore and our innate immune system is the first step leading to infection.

The innate immune system is made up of cellular immunity and humoral immunity. While the first is well described, the second, consisting of soluble mediators, is essential for anti-aspergillus immunity but relatively little studied. The study of soluble mediators present in the alveolar fluid interacting directly with the Aspergillus spore would make it possible to analyze the first stages of infection. The analysis of the proteome present in the bronchoalveolar lavage of uninfected patients, suffering from various forms of aspergillosis and suffering from other types of infections would make it possible to highlight the essential and specific components of anti- immunity aspergillary.

The objective of this study is to analyze the protein profiles of innate immunity in the pulmonary alveoli in the absence or presence of Aspergillus or non-fungal infection in order to highlight the soluble mediators of the more specific immunity of the Aspergillosis.


Eligibility Criteria:
Inclusion Criteria for the case group (IPA / CPA): :

1. Patient who are more than 18 years old
2. Patients for whom bronchial endoscopy with BAL is performed as part of an exploration of IPA or CPA in current care. Probable or proven invasive pulmonary aspergillosis according to the criteria of the EORTC (2019).
3. Patient who has given his consent.

Inclusion Criteria In the control group :

1. Patient who are more than 18 years old
2. Patients for whom bronchial endoscopy with BAL is performed as part of an exploration of diffuse interstitial lung disease or a lower respiratory infection other than Aspergillus in routine care. Chronic pulmonary aspergillosis according to the criteria of ESCMID / ERS (2016)
3. Patient who has given his consent.

Exclusion Criteria for the case and the control group:

1. Pregnant woman
2. Patient deprived of their rights
3. Patient under tutorship or guardianship or under the protection of a conservator
T-ICD vs S-ICD Shocks: Myocardial Injuries

Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after defibrillation testing (DFT). The aim of our study was to investigate the association between S-ICD vs T-ICD shocks and acute cardiac damage in humans, as evaluated by means of sensitive and highly specific circulating biomarkers


Eligibility Criteria:
Inclusion Criteria:

patients who met the criteria for ICD implantation according to the current guidelines

Exclusion Criteria:

-
LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients

The aim of this trial is to find out if there are any differences in the profiles of acute and late adverse effects among men with low and intermediate risk prostate cancer treated either with low dose-rate brachytherapy or hypofractionated external radiotherapy (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each treatment will be analysed.

Prostate cancer (PC) is the most common solid malignancy among the men in the Western world. The classification to low, intermediate and high risk groups is determined by the PSA, Gleason score and clinical TNM status at the moment of diagnosis. There are several treatment options available for patients with low and intermediate risk PC and generally their prognosis is good. The men live long after their radical treatments and they have to live with the possible adverse effects caused by the treatment.

In this prospective, randomised clinical trial we are comparing two radiotherapy modalities to find out if there are differences in the acute and late adverse effects among men treated either by low dose-rate (LDR) brachytherapy or hypofractionated external radiotherapy. Also the PSA-responses and cost utilities will be analysed. The number of patients recruited for the study is 60 and the patients will be randomised 1:1 to each treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* biopsy proven adenocarcinoma of the prostate
* Gleason score ≤ 3+4
* clinical and radiological TNM T1c-2c, N0-X, M0-X, PSA ≤ 20ng/ml and WHO 0-2
* low or intermediate risk prostate cancer according to National Comprehensive Cancer Network (NCCN) classification

Exclusion Criteria:

* clinical TNM ≥ T3
* Gleason score ≥ 4+3
* high risk prostate cancer according to NCCN classification
* history of cancer (other than PC) during the past 5 years (excluding basalioma and squamocellular carcinoma of the skin)
* previous pelvic radiotherapy
* previous active treatments of prostate cancer (active surveillance allowed)
* bilateral hip prothesis or other implant impedes pelvic TT or MRI imaging
* clopidogrel medication
* poor co-operation
* life expectancy \< 5 yrs
A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.

Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Many reports have focussed on evaluation of fluid responsiveness using various parameters such as pulse pressure variation (PPV) or stroke volume variation (SSV) derived from invasive or semi-invasive monitoring. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on thorax. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or ASA II patients aged 20-80 undergoing neurosurgery in supine position

Exclusion Criteria:

* Pre-existing arrythmic disorders
* Congestive heart failure required medical treatment
* Preoperative Creatinine 1.3mg/dl
* observing self respiration during the study interventions
* Bleeding tendency
* Severe brain edema
Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy

The role of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in patients undergoing hysterectomy remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative methadone in patients scheduled for same day hysterectomy is therefore conducted.

Background with aim: Hysterectomy is the most common major gynaecological procedure in the world and hysterectomy on benign indications are increasingly being performed as same-day surgery. Therefore, perioperative anaesthesia has moved towards the use of very short-acting opioids with the incitement to speed up extubation and facilitate hospital discharge. However, the potential consequence is that more patients experience pain and discomfort.

Methadone has several desirable pharmacological features, and a single intraoperative dose of the long acting opioid could therefore theoretically expand the analgesic window and reduce postoperative opioid consumption compared to the more conventional use of short-acting opioids. The aim of this study is to investigate the effect of a single-dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for hysterectomy for benign indications. Our primary hypothesis is that intravenous perioperative methadone reduces opioid consumption (oral cumulative equivalent dose) by 30% during the first 24 postoperative hours compared to intravenous morphine.

Methods: 126 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: an intervention arm (methadone 0.2 mg/kg ideal body weight) and a control arm (morphine 0.2 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2018-004351-20) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-365-18).

Hypothesis: The results will probably be applicable to other types of surgery involving visceral pain, and thus the present study has the potential to improve the pain management for a large number of patients undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled for elective laparoscopic hysterectomy for benign indications

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) physical status IV or V
* prolonged QT-interval assessed by electrocardiogram (\> 440 milliseconds)
* Existing treatment with medications prolonging the QT-interval
* Hysterectomy due to malignancy or acute bleeding disorders
* Allergy to study drugs
* Preoperative daily use of opioids
* Severe respiratory insufficiency
* Heart failure
* Acute alcohol intoxication/delirium tremens
* Increased intracranial pressure
* Acute liver disease
* Acute abdominal pain
* Liver insufficiency
* Kidney insufficiency
* Treatment with rifampicin
* Breastfeeding
* Inability to provide informed consent.
A Single Arm Pilot Trial of a Social Network Intervention

The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.

The objective of this study is to conduct a single arm pilot study to assess the feasibility and acceptability of the SONATA intervention among older patients with advanced cancer. We hypothesize that the SONATA intervention will be feasible \[≥70% enrolled patient subjects (excluding those who die during the study) will complete at least 3 of the SONATA sessions\] and acceptable \[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\]

Eligibility Criteria:
Patient

Inclusion Criteria:

1. Age ≥60 years
2. A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist
3. Able to speak English
4. Able to provide informed consent

Exclusion Criteria:

1) Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team

Network Members:

Inclusion Criteria:

1. Age ≥18 years
2. Identified as a network member by patient subjects (up to 10 network members)
3. Able to speak English
4. Able to provide informed consent.

Exclusion Criteria:

None
Safety, Efficacy of Eglandin® in Living Donor Liver Transplanted Patient (PROVISION)

The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST levels followed by Eglandin administration were assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Primary living donor liver transplantation
2. Patient received modified right lobe graft
3. Aged between 19 to 65 years
4. Informed consent

Exclusion Criteria:

1. ABO incompatibility
2. Dual liver transplant patient from 2 donors
3. History of liver transplantation or other organ transplantation
4. Transplantation of other organ(s) at the time of liver transplantation
5. Use of artificial liver device prior to liver transplantation
6. UNOS status Ⅰor ⅡA
7. History of malignant tumor within 5 years
8. Not included in Milan liver transplant criteria for hepatocellular carcinoma
9. Patient with WBC \< 2,000/mm3 or ANC \< 900/mm3 or platelet \< 30,000/mm3 at the time of screening
10. Patient exposed to severe systemic infection requiring treatment
11. Positive response for HIV in either donor or recipient
12. Prior administration of other investigational product within 30 days (or 5 times the half life) from date of screening
13. Women of childbearing age without effective contraception, breast feeding and pregnant women
14. Substance abuser, patient with metal disorder, and otherwise legally not eligible patient
15. Not eligible to participate at discrete of study investigator
Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section

Cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. Although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. Cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. Among cardiac diseases, Rheumatic Heart Disease is the commonest cardiac disease complicating pregnancy.

The subarachnoid block is the most used anesthesia technique for conducting a cesarean section. The incidence of hypotension following this procedure is as high as 20-40% in pregnant patients. Similarly, bradycardia is also commonly associated with post-SAB, and the reported incidence is around 13%. Spinal anesthesia results in sympathetic block leading to a decrease in systemic vascular resistance and hypotension. Hypotension caused by subarachnoid block is physiologically compensated by an increase in heart rate. However, if vagus nerve-mediated Bezold-Jarisch reflex gets stimulated, then the cardiac autonomic balance gets shifted towards the parasympathetic nervous system leading to bradycardia, which further precipitates hypotension.

Levobupivacaine is a highly potent long-acting local anesthetic with a comparatively slow onset of action. Compared to bupivacaine, it has a lower tendency to block deactivated cardiac sodium and potassium channels with a more rapid rate of dissociation. It has reduced cardiac toxicity on overdose intravenous administration due to its faster protein binding rate. Plain levobupivacaine is isobaric to CSF. One of its advantages is that it has a more expectable spread. Several studies have revealed the reduced occurrence of various side effects (such as nausea, vomiting, bradycardia, and hypotension) when levobupivacaine compared with bupivacaine for spinal anesthesia used for cesarean delivery. It has been suggested to use 12.5-13.5mg levobupivacaine for effective spinal anesthesia for cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatic female patients in the childbearing period scheduled for elective cesarean sections

Exclusion Criteria:

* Patients with eclampsia and pre-eclampsia history,
* uncontrolled diabetes mellitus, morbid obesity,
* coagulation abnormalities,
* vertebral deformities, also patients who refused regional anesthesia,
* having contraindications to spinal anesthesia
Investigation of the Effect of Internet Addiction Level in University Students

The internet, which has become a part of our daily life; serves many purposes such as quick access to information, e-mail, and chat, banking and shopping, having a good time, using social networking sites. Internet addiction, which was first defined by Ivan Goldberg in 1996, is defined as the inability to control internet use, which causes pressure, feelings of anxiety, and dysfunctional behaviors in daily life activities. Social media, digital games and smartphone addiction are among the addiction types whose active ingredient is the internet, and internet addiction is expressed as a whole, regardless of the type of addictive application or activity. Considering that internet use is common among young people, one of the risk groups in terms of internet addiction is university students. As a matter of fact, Günay et al. stated that approximately 8% of university students are at risk of internet addiction.

In the literature, musculoskeletal problems and pain in the thumb and related joints, reduction in pinch strength, and hand function have been reported with smartphone use. In addition, a significant relationship was found between the time spent surfing the Internet and pain at the base of the thumb. However, to the best of our knowledge, no study has been found that examines the effect of internet addiction level on thumb pain threshold, hand strength and manual dexterity in university students. The aim of our research is to determine the level of internet addiction in university students and to examine the effect of internet addiction level on thumb pressure pain threshold, hand strength and manual dexterity.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Being a student at Bandırma Onyedi Eylül University
* Willingness to participate in the study

Exclusion Criteria:

* Any injury involving the upper extremity in the last 6 months
* Any surgical operation involving the upper extremity in the last 6 months
* Any systemic disease
* Any neurological problems
* Use of any psychiatric medication
Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison

The SAMBA study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a GP-based treatment on the other hand (standard-of-care group).

In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage patients as they wish.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-Tr criteria for alcohol dependence
* Clinical indication for alcohol detoxification
* Social Insurance
* Signed Consent Form for participation

Exclusion Criteria:

* Previous history of seizures
* previous history of delirium tremens
* acute or chronic liver failure
* contraindication for using diazepam
* average daily alcohol use of 300g of ethanol
* SADQ score of 30 or more
* chronic treatment with baclofen or disulfiram
* current DMS-IV-Tr criteria for major depressive episode, or lifelong history of bipolar or psychotic disorder
* any physical, cognitive, or psychiatric disorder that expose the subjects to enhanced risks (at the discretion of the investigator)
* previous participation in the SAMBA study
* social isolation of homelessness (at the discretion of the investigator)
* pregnancy or breastfeeding
* guardianship or curatorship
* previous participation in a biomedical study over the previous month