cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Primary Aldosteronism in Atrial Fibrillation

This is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at least 30 seconds (either paroxysmal or persistent or permanent).

Exclusion Criteria:

* Diagnosis of primary aldosteronism
* Diagnosis of heart failure, treated with mineralocorticoid receptor antagonists
* Inability to be subjected to any confirmatory tests for primary aldosteronism
* Acute vascular event (acute coronary syndrome, stroke, acute peripheral vascular event) within last 6 months
* Renal replacement therapy
* Incompetence of unwillingness to provide written informed consent
Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill

Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective comparison study in patients undergoing regular intrathecal pump refill

Intrathecal drug therapy with implantable intrathecal pumps is being utilized increasingly for the treatment of chronic refractory pain and spasticity. However, performing the regular refill procedures of the pumps with the commonly performed "blind" technique caries the potential risk of medication injection into the subcutaneous tissue, which can lead to an overdose.

Objective: The primary purpose of this study is to assess the accuracy of the ultrasound-guided technique for the refill procedure compared to the blind technique in subjects undergoing regular refills of their intrathecal pumps for the treatment of chronic non-malignant pain or spasticity.

Study design: Mono-center prospective efficacy and reliability study comparing two approaches to enter the fill port. Study population: The investigators will include patients with an intrathecal pump for the treatment of chronic non-malignant pain or spasticity, undergoing regular refills of their intrathecal pumps at our Centro Terapia del Dolore at the Ospedale Italiano a Viganello(EOC, Switzerland). Intervention: Two different experienced clinicians will perform one time the blind technique and two times the ultrasound-guided technique on all patients.sample size calculations can be performed. The sample size i.e. n=25 patients in NSI-TD-001 Protocol v. 1.0 Final: August 4th, 2014 Confidential Page 31 of 40 total assessed 6 six times is therefore based on practical grounds related feasibility to duration of inclusion (i.e. one year). This would imply 50 paired assessments for both fill port accuracy assessment and intra-rater reliability. The investigators believe based on clinical experience that this number would suffice to detect a difference between methods. Likewise, although no formal power calculation are available for ICC based reliability assessment, as a rule of thumb 50 paired assessments are usually considered adequate to evaluate intra-rater liability.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of enrollment;
* The patients are treated for chronic non-malignant pain or spasticity with an intrathecal
* programmable infusion pump and undergo regular refills of their pumps in our clinic.
* Able to provide adequate given written, informed consent to participate in this study.

Exclusion Criteria:

* patient refusal to participate or provide informed consent standard exclusions; pregnancy, lactation, treatment with other investigational products.
* other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction,
* cardiovascular disease).
* infection at the puncture site -participation in another study.-
The Effects of Vasopressin on Attention Control

The main aim of the present study is to investigate whether intranasal vasopressin (20IU) could influence attention control in a social-emotional saccade/antisaccade eye-tracking paradigm.

A number of previous studies have reported vasopressin's effect on human social behavior and social cognition, although it remains unclear whether vasopressin could modulate attention allocation including stimulus-driven bottom-up control and goal-directed top-down control. In the current randomized, between-subject, placebo controlled study, 89 healthy male subjects will be recruited and receive either vasopressin (20 IU) or placebo control administered intranasally. 45 minutes after treatment subjects will be required to complete a social-emotional saccade /antisaccade eye-tracking paradigm. The paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore social- and emotion-specific effects of vasopressin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Non smokers

Exclusion Criteria:

* Previous or current medical, psychiatric, neurological disorder
* Regular medication
* Use of any psychoactive substances in the 24 hours before experiment
* Contra-indications for vasopressin
* Contra-indications for eye-tracking data acquisition
Virtual Reality and Technologies for Elderly

The objective of this clinical trial is to understand the determinants and opportunities for acceptance of immersive technologies to support physical, cognitive, and social health and the possibilities for "aging well" among the new generation of older adults. The main questions it aims to answer are:

* What are the needs and expectations in terms of immersive activities and intervention methods according to age?
* Do different game modes influence the needs and expectations in immersive activities of this population? 50 participants will be asked to complete a preliminary questionnaire about their activity habits and preferences. They will then be invited to participate in individual or multiplayer virtual reality game trials, a post-trial discussion about their experience and a questionnaire completion.


Eligibility Criteria:
Inclusion Criteria:

* Be 50 years old or older

Exclusion Criteria:

* Having functional limitations
* Having cognitive impairments
* Being at risk of epilepsy
* Not being autonomus
* Having a pacemaker
Pacing in Heart Failure With Preserved LVEF

A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes.

The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board \[CVUHB\]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography.

All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order:

Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP


Eligibility Criteria:
Inclusion Criteria:

1. Clinical features consistent with heart failure. All patients will have symptoms of moderate to severe heart failure with New York Heart Association (NHYA) classification III or IV symptoms (for at least 3 months).
2. LV Ejection Fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction.
3. Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
4. Adults (over 18 years)
5. Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
6. Two weeks or more following final dose of vaccination against coronavirus.

Exclusion Criteria:

1. Inability to provide informed consent.
2. Enrolment in other clinical studies.
3. BMI more than 35
4. Objective evidence of significant lung disease on formal lung function testing
5. Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery
6. Acute coronary syndrome (within the previous three months)
7. History of atrial fibrillation (AF)
8. Renal insufficiency requiring haemodialysis
9. Life expectancy less than 6 months
10. Prosthetic heart valves
11. Blood coagulation disorders
12. Immunocompromised patients (e.g. AIDS, patients on steroids, cytotoxic drugs, and radiation therapy)
13. Currently pregnant, or intending to conceive.
14. Recent positive Covid test (up to 14 days prior to pre-assessment).
Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p

1. Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.
2. To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.

The "standard tincture quadruple therapy" and the "proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy" recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a "Tetracycline combined with levofloxacin quadruple therapy" for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (\> 95%). A randomized controlled trial confirmed that the elimination rate of "Tetracycline combined with levofloxacin quadruple therapy" was better than "proton pump inhibitor combined with fluoroquinolone" after "standard triple therapy" and "non-tank tetratherapy" sterilization failure. Triple therapy with amoxicillin.

Eligibility Criteria:
Inclusion Criteria:

1. at least 20 years old
2. subject was failure for the first line therapy of Helicobacter pylori

Exclusion Criteria:

1. Those who are allergic to the drugs used in this study
2. Those who have had a stomach surgery
3. Those who have antibiotics within four weeks of treatment
4. Those who have severe cirrhosis, uremia or malignancy
5. Those who are a pregnant woman or a woman who breastfeeds
Study of Silicone Material Inserts To Treat Burn Scars

The purpose of this study is to determine if the use of silicone material inserts within pressure garments is effective in decreasing hypertrophic burn scar formation as compared to standard pressure garment therapy.

Surgical revision, potential hospitalization, and extensive post-surgical rehabilitation may be required for the revision and correction of hypertrophic burn scars to restore function and prevent disability. This in turn results in an increased financial burden to the medical system. More importantly, the patient is required to undergo an additional invasive medical procedure that can potentially create further hypertrophic scarring.

Prevention and reduction of hypertrophic scars with non-invasive, cost effective, and evidence based treatment modalities is therefore the most desirable approach. Two of the most generally accepted methods of non-invasive treatment, pressure garments and silicone gel sheeting, have been demonstrated to individually treat hypertrophic scarring. Recently, burn therapists have begun to use silicone bonded material inserts within pressure garments following the logical deduction that the two therapeutic techniques can be combined to resolve many of the cited individual disadvantages, while reaping the benefits of each individual modality. It is the aim of this study to determine the efficacy of these silicone bonded material inserts within pressure garments in the treatment of hypertrophic scarring.

Eligibility Criteria:
Inclusion Criteria:

* patients who would normally receive pressure garments
* presence of an acute burn to an upper or lower extremity that requires treatment with a sheet or meshed graft
* Minimum 4% total body surface area graft dimension (this must include areas above and below the elbow or on medial and lateral aspects of the calf
* Between 16 years and 60 years of age
* Patient must consent to the study or obtain consent from guardian if \<18 years of age
* Must be available for follow-up at 1 month, 3 months, 6 months, and 12 months post initiation of treatment

Exclusion Criteria:

* Presence of pre-existing hypertrophic or keloid scarring
* Pressure garments initiated greater than 2 months post discharge from hospital
* Pre-existing decrease in range of motion of affected extremity
* One treatment area with a prolonged healing phase or which had been treated differently in comparison to adjacent treatment area
* Patient unable to comprehend or participate in self reporting
A New Decisional Tree for the Management of Acetabular Fractures : Monocentric Observational Study

Acetabular fractures are challenging fractures to treat. Many fracture patterns occur, in a deep anatomical area surrounded by numerous vascular and nervous elements, generally in a polytraumatic context . A reduction with less than 2 mm of incongruence is generally considered acceptable, limiting post-operative osteoarthritis that could rapidly require total hip arthroplasty. Due to the long learning curve, this surgery is limited to large reference centers

. In the last twenty years, the main series published in the literature are small series due to the rarity of the fractures and their trauma context (loss of follow-up, polytrauma patients...). The large variety of fracture patterns according to the Letournel classification creates a spread in patient distribution and decreases the power of statistical analysis. That is the reason why big series are rare and only a few of them allow significant conclusions . The other studies are meta-analyses with their limitations

The lack of consensus makes it difficult to interpret the results between series, so the investigators developed a decision tree to address this knowledge gap.

The aim of this study is to assess and compare the results of a decisional tree for acetabular fracture in a large cohort of patients from a well-known experimental trauma center.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient at the time of injury
* Acetabular fracture
* Pre-operative standard X-ray image
* Pre-operative CT image
* Post-operative X-ray standard image (AP-alar and obturator views)
* Post-operative CT scan.
* Willingness and ability to participate in the study

Exclusion Criteria:

* Ipsilateral fracture femoral and/or associated pelvic ring fracture (Floating Hip C or B)
* Pregnant, lactating women
* Subject under administrative or judicial supervision
Erector Spinae Plane Block (ESPB) Versus Quadratus Lumborum Block (QLB) for Postoperative Analgesia After Caesarean Section

Management of pain after caesarean section represents an important anesthesiologic issue, since it is often suboptimal, leading to delayed functional recovery and chronic pain. Currently, the postoperative analgesic strategy mostly relies on intrathecal morphine (ITM) and multimodal analgesic regimen. Recently, the need for alterative opioid sparing techniques is emerging. Paraspinal fascial plane blocks, as quadratus lumborum block (QLB) and erector spinae plane block (ESPB) performed at T9 level, have therefore been proposed as alternatives to ITM, because of their demonstrated effect on visceral and somatic pain.

The aim of the study is to assess the efficacy, the feasibility and safety of bilateral ESPB compared to bilateral QLB for the management of postoperative pain after ceasarean section conducted under spinal anesthesia without ITM.


Eligibility Criteria:
Inclusion Criteria:

- Patients ASA 2 with normal singleton pregnancy, scheduled for elective caesarean section without intrathecal morphine, who underwent bilateral ESPB at the end of surgery an who gave informed consent to data collection.

Exclusion Criteria:

* Contraindications to spinal anesthesia;
* Contraindications to or a history of opioid dependence;
* Allergy to local anesthetics, acetaminophen, NSAIDs
* Inability to understand pain assessment scales or to use Patient Controlled Analgesia (PCA) pump;
* Patient refusal.
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage

Guidelines for photodynamic therapy (PDT) of actinic keratosis recommend pretreatment with curettage. The impact of curettage on the treatment effect is, however, not known. The present study aimed to evaluate whether daylight-PDT without curettage would reduce treatment effect compared to daylight-PDT with curettage.


Eligibility Criteria:
Inclusion Criteria:

- Multiple actinic keratosis on the forehead or scalp

Exclusion Criteria:

* Known allergy to methyl aminolevulinate
* Porphyria
* Pregnancy
* Lactation
Transient ECG Changes in Patients With Acute Biliary Disease

Background:

The importance of ischemic ECG changes including St segment elevation, ST segment depression or T wave inversion that indicate myocardial ischemia are well established and require appropriate investigation and treatment.

However, there is an abundance of clinical situation, with apparently ischemic ECG change not indicate traditionally coronary artery related ischemia and therefore require prompt recognition and treatment of underlying condition, that may be serious and life-threatened. For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte abnormalities, intracranial hemorrhage and hypothermia.

Together with them, an ECG ST segment changes may appeared in abdominal serious illness such as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various vasoactive and toxic for myocardium substances released, the cause of ST segment changes in cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma rennin activity resulted by distension of the gallbladder.

The certain proportion of the patients with ECG changes actually didn't have coronary artery disease(9,15) or other acute cardiac condition and therefore require treatment of the underlie illness only without spend the time for cardiac investigation or special treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or unnecessary cardiac catheterization.

In the medical literature the investigators found some case reports and works about the ECG changes in acute biliary disease in patient with knowing cardiac disease and without it, but actually incidence of ECG changes that suggest but not represent an acute coronary illness isn't knowing.

Therefore this is necessary to investigate actually incidence of ECG changes that mimic acute coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical and laboratory characteristics that helps to differentiate this patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients from age 18 and up to 75years old.
2. Causes of admission to the ED are acute cholecystitis, biliary colic, acute cholangitis
3. The patient is willing to participate in the study and is able to sign an informed consent form.

Exclusion Criteria:

1. Elective hospitalization with known and not acute condition.
2. Inability to give inform consent .
3. Sepsis as complication of illness.
4. Chronic ECG changes known by medical history.
5. Knowing history of IHD.
6. Previous cardiac catheterization with documented stenosis of at least 1 major coronary artery equal or more 50%.
Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients

The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients. To reduce the negative impact of the stoma, patients are seen in preoperative consultation by the stoma nurses. This consultation allows to show the patients the appearance of a stoma (through a photograph), the equipment used and how it works.

In 2016, McKenna et al. showed the interest of marking (with felt pen) the ostomy site on the abdomen in preoperative. In this study, patients with preoperative marking had a higher post-operative quality of life score than patients without marking (p=0.03).

Quality of life was assessed using the STOMA-QOL score. This quality of life score is specific for ostomy patients. It assesses 4 dimensions: sleep, intimate relationships, relationships with family and close friends, relationships with people other than family and close friends. This questionnaire includes 20 questions and has been validated in 5 languages including French.

The aim of this pilot study is to evaluate the post-operative quality of life of ostomy patients who have benefited from a preoperative therapeutic education session with the placement of the 3D printed ostomy button versus felt-tip marking, during the 15 days prior to the operation.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old,
* First ileostomy with indication for temporary stoma placement,
* Patient with scheduled surgery,
* Patient who has the capacity to understand the protocol and has given consent to participate in the research,
* Patient with social security coverage.

Exclusion Criteria:

* Patient \< 18 years old,
* Patient with an indication for placement of a permanent stoma,
* Emergency surgery patient,
* Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception,
* Patient under guardianship, curators or legal protection,
* Patient participating in another interventional clinical research protocol involving a drug or medical device.
Cognitive Function and Health-related Quality of Life After Neuro-intensive Care

The study will provide information on cognitive impairment and Health related quality of life in patients surviving 12 months after acute brain injury, generate a hypothesis of useful variables to predict cognitive impairment or low levels of HRQoL, and potentially inform interventions for the prevention and treatment of cognitive impairment following neuro-ICU stay.

The aim is to 1) measure the frequency and extent of cognitive impairment after acute brain injury at six and 12-months after neuro-Intensive care unit (ICU) admission 2) explore the association between cognitive impairment at six and 12 months after ICU admission with the following potential risk factors: duration of ICU delirium (days), duration of sepsis (days), duration of post traumatic amnesia (days) and the severity of brain injury (initial Glasgow Coma Scale , 3) describe Health related quality of life, functional disability and frailty at six and 12 after ICU admission and 4) explore the association between the functional disability, frailty and health-related quality of life at 12 months after ICU admission

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury
* Spontaneous intracranial hemorrhage
* Ischemic stroke
* An anticipated stay in the neuro-ICU for 48 hours or longer.

Exclusion Criteria:

* Persistent coma defined as Richmond Agitation-Sedation Scale (RASS) -5 to -3 throughout the neuro-ICU stay
* Congenital brain injury
* Suspected pre-existing Cognitive impairment (Informant Questionnaire on cognitive decline in the elderly (IQCODE): 3.3 or more) (regardless of cause)
* Permanent residence outside Denmark
* Inability to communicate in Danish