cyrilzakka/clinical-trials huggingface dataset:
The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis

The aim of this study is to prospectively investigate the additional diagnostic value of broad range PCR targeting the 16 ribosomal DNA in diagnosis and management of patients with infective endocarditis who are candidate for surgicaltherapy;

Study protocol is divided into four different phases:screening, pre-operative clinical assessment (T-1), cardiac surgery (T0) and follow-up period (T4 eT90).

During the screening phase, patients will be assessed to determine whether they met the study inclusion/exclusion criteria. After signing the informed consent, patients will go through a preoperative clinical evaluation (T-1). The following assessments are carried out the day before surgery: recording patient's generality, present antibiotic therapy and possible results of blood cultures performed prior to recruitment; - Twelve-lead ECG; - chest X-ray - transthoracic echocardiogram (TTE); -. three pairs of blood cultures from three different blood sampling sites. In cases of complicated endocarditis, the presence and location of septic embolisms is recorded (using Total body CT scan imaging), signs of heart failure evaluated and operability criteria are assessed. On the day of cardiac surgery (T0), main intraoperative data (valve findings, type of prosthesis, surgery time, cardiopulmonary bypass time and aortic cross clamping time) will be gathered; the excised valve was sent partly to the microbiology laboratory for culture and molecular tests and partly to the pathology Laboratory.

After cardiac surgery, patients continued to be monitored for a follow up at four (T4) and 90 (T90) days after surgery. During the follow-up period, information was collected on the patient's clinical status (vital parameters) and the antibiotic treatment performed. The same blood tests performed at T-1 are repeated at T4 and T90. All this data was recorded on a dedicated database.

Eligibility Criteria:
Inclusion Criteria:

1. patients older than 18 years, with diagnosis of IE on a native or prosthetic valve and with a surgical indication for heart valve replacement using extracorporeal circulation (CPB).
2. patients who have signed informed consent to the partecipation of the study

Exclusion criteria:

1. patients younger than 18 years
2. Failure to sign consent for personal data processing and/or study participation
3. Participation in other experimental studies
4. Patients who did not complete the examinations under study (culture test on blood and excised valve, molecular tests)
Prizvalve® Transcatheter Valve-in-Valve Implantation Exploratory Study

The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
2. Age≥18 years old who are not in pregnancy or lactation;
3. NYHA Function Class≥ II;
4. Patient who is anatomically suitable for the implantation of the Prizvalve® ;
5. According to heart team , patient is intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement due to other severe comorbidities ;
6. Heart team agrees valve implantation will likely benefit the patient;
7. Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Patients with other valvular diseases that require simultaneous intervention;
2. Patients with other heart diseases that require simultaneous intervention;
3. Estimated life expectancy \< 12 months;
4. Failing valve has moderate and above paravalvular regurgitation;
5. Failing valve in unstable ore not structurally intact;
6. Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;
7. Anatomical characteristics that would preclude transcatheter valve implantation;
8. Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;
9. Patient with acute myocardial infarction within 30 days;
10. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
11. Patient with hypertrophic cardiomyopathy with obstruction;
12. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
13. Patients with active infective endocarditis or other active infections;
14. Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \< 20%;
15. Patients who cannot tolerate anticoagulant or antiplatelet therapy;
16. Patients with severe untreated coronary artery stenosis requiring revascularization;
17. Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack;
18. Patients who refuse surgical treatment in emergency situations under any circumstances;
19. Patients who have severely disabled Alzheimer's disease and inability to take care of themselves;
20. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
21. The investigator judged that patient with poor compliance and could not complete the study as required.
Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke

Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere (UH) transiently improves motor function in patients in the chronic phase after stroke. The goal of this study is to investigate effects on motor recovery of low-frequency rTMS of the UH, administered in the subacute phase after stroke.

Stroke is a major cause of disability and worldwide. Hand motor impairment is frequent after stroke. Even mild impairments of the upper limb negatively impact disability and quality of life in these patients significantly contributes to disability. Therapeutic alternatives for hand motor rehabilitation are deeply needed.

Repetitive transcranial magnetic stimulation (rTMS) has emerged as a potential tool to improve hand motor performance after stroke. While high-frequency rTMS (HF-rTMS) often increases motor cortical excitability, LF-rTMS often has the opposite effect. Up-regulation of excitability in the affected hemisphere by HF-rTMS or down-regulation of the UH by LF-rTMS can restore the balance in inter-hemispheric inhibition and hence, facilitate movement of the paretic hand Both strategies, as well as the combination of both, have yielded encouraging results when applied in proof-of-principle, single-session studies to patients with mild hand motor impairment in the subacute and chronic stages after stroke. However, few rTMS studies included patients less than six months after stroke, and effects of LF-rTMS of the unaffected hemisphere in patients with severe motor impairment in the subacute phase have not been yet reported.

The investigators opted for a novel approach to enhance hand motor recovery, by examining feasibility, safety and preliminary efficacy of either active or sham LF-rTMS of the UH or sham rTMS as add-on therapies to outpatient customary rehabilitation, to patients with mild to severe hand paresis, within 5-45 days after unilateral ischemic stroke. The investigators hypothesize that, at this stage, LF-rTMS will be feasible even in patients with severe motor deficits, will have minimal adverse events and will enhance effects of customary rehabilitation on hand motor performance.

Eligibility Criteria:
Inclusion Criteria:

* First-ever ischemic stroke in the internal carotid artery territory confirmed by CT or MRI, 5-45 days before, leading to contralateral hand weakness
* Age, 18-80 years

Exclusion Criteria:

* Cardiac pacemaker
* Pregnancy
* Implantable medication pump
* Intracranial hypertension
* History of seizures
* Metal in the head
* Decompressive surgery
* Other neurological diseases
* Shoulder pain
* Joint deformity in the paretic upper limb
* Severe chronic disease such as end-stage cancer or end-stage renal failure
* Inability to provide informed consent due to severe language or cognitive impairment
Alcohol Detection Via Bioimpedance Mesurements

Examination if the bioimpendanz measurement can be used for the determination of the alcohol content in human blood.

Furthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer and one blood test.

In this clinical trail it will be analyzed, if it is possible to assess the blood alcohol content (BAC) with the bioimpedance devices (SFB7, ImpediMed; Nicomo).

This technology is non-invasive an can be measured by using conductive electrodes, capacitive electrodes or inductive measurement systems.

The BIS-values will be compared with an official breathanalyzer (Alcotest 7110 Evidential MK III, Dräger, Lübeck, Germany).

Furthermore one blood sample will be taken and analyzed with the ADH method as the current gold standard at the end of the trail.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* able to give informed consent
* Inconspicuous laboratory and drug screening

Exclusion Criteria:

* electrophobica
* alcoholphobica, -allergy
* metallic ans / or electric implants
* underage persons
* interactively medication
The Use of FDG-PET in Patient With Hodgkin Lymphoma: a Population Based Study From Northern Italy

Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. As no data are available to support the use of early assessment of response for adapting and modifying subsequent treatment, the use of PET should be limited only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is included in the current management of patients with HL at baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed to verify how PET is currently used in the clinical setting and to assess if and how results of PET scanning are used for supporting treatment and clinical decisions.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed classical Hodgkin lymphoma according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted).
2. Clinical stage I-IV.
3. No previous chemotherapy, radiotherapy or other investigational drug for HL.

Exclusion Criteria:

1. None.
Pneumoproteins Expression in the Organ Donor

Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. We will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.


Eligibility Criteria:
Inclusion Criteria:

All the organ donors for lung grafts.

Exclusion Criteria:

none
To Evaluate Transport Safety Between Different Scanning Methods for Patients in the Intensive Care Unit (ICU)

The goal of this study is to assess how safe it is for critically ill patients in the Intensive Care Unit (ICU) to undergo a PET scan. A PET scan is a type of medical imaging used to help determine why a patient is sick. It is similar to a CT scan but involves a small amount of radioactivity to highlight areas of concern in the body.

For a PET scan, patients need to be transported from the ICU to the scanning room, which can be risky because ICU patients are often very fragile. After a patient gets the PET scan injection, their body gives off a small amount of radiation for a short time. Because of this, doctors and nurses have to keep some distance to protect themselves. This means they keep an eye out for the patient from a bit further away than normal. This makes the procedure slightly riskier, especially for very sick patients.

This study aims to answer the question:

Is getting a PET scan riskier for ICU patients than a regular CT scan?

All patients in this study will continue to receive their usual critical care. Researchers will closely monitor the scanning process to evaluate its safety.

PET scans are already widely used to detect cancer, but new advancements may allow us to use them more often to diagnose infections. Before this can become routine practice, we need to ensure that PET scanning is just as safe as other commonly used imaging techniques. This study will assess all ICU patients undergoing a PET scan-regardless of the reason for the scan-to determine how safe the procedure is in critically ill individuals.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving PET/CT during ICU admission (any indication)
* Patients undergoing CT Thorax/Abdomen (matched cohort)

Exclusion Criteria:

* CT-scan for any acute indication (acute danger to vital parameters).
* CT-Cerebrum
* Registrion in the dutch Objection to medical research registry.
Prospective Study Investigating the Role of Occupational Exposure on Sinus Surgery Outcome

The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune, infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus surgery (FESS) is the therapy of choice. From literature it is known that 10% of patients that undergo FESS, need revision surgery within the 3 years following initial surgery. Causes of failure are multiple and not fully understood.

As is the case in patients suffering from occupational rhinitis (OR), a subgroup of patients with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology induced by occupational factors as well. No data are currently available on how these factors may contribute to the disease manifestation, whereas negligence of these factors as potential causes of disease may lead to the chronicity of rhinosinusitis, aggravate the mucosal condition and even give rise to the induction of bronchial symptoms. There exists no documentation on the role of the occupational agents on chronic sinus disease.

This prospective study aims at providing data about the exposure levels of patients that undergo sinus surgery and correlate them with both subjective and objective postoperative parameters. This will be done by providing a questionnaire that was developed at our department to all patients that are planned for sinus surgery at the participating centers. This questionnaire asks for medical history, current sinonasal symptoms, professional history and recreational occupation. An extensive list of occupational agents is given and patients are asked to indicate those that they encounter at work or during recreational activities. This will be followed by an extensive clinical investigation including nasal endoscopy. These investigations (questionnaire and clinical examination) will be repeated at 3 months and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for sinus surgery because of recurrent acute sinusitis or chronic sinusitis with or without nasal polyps.
2. Age \> 18 and \< 65 years
3. Signed informed consent
4. Willingness and capability to fill in questionnaire.

Exclusion Criteria:

1. Patient with diagnosed cystic fibrosis or primary ciliary dysfunction syndrome
2. Patients that undergo FESS for antrochoanal polyp
3. Patient that undergo FESS for a malignant process
4. Patient that are diagnosed with sarcoidosis or any type of vasculitis
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps

This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

The main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
2. Bilateral CRSwNP.
3. Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
4. Nasal Congestion Score of \> 2 at screening and a weekly average severity of \> 1 at time of randomization.
5. Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.

Exclusion Criteria:

1. Patients with other nasal diseases or symptoms.
2. Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
4. History of cancer.
5. Known or suspected history of immunosuppression.
6. Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes

The purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA), with the current standard of care of patient-directed auditory training in improving common measures of speech recognition and cochlear implant (CI) specific quality-of-life in new adult CI recipients in their first year post-activation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of bilateral moderate-to-profound sensorineural hearing loss who are undergoing unilateral or simultaneous bilateral cochlear implantation at the Mayo Clinic in Rochester MN.

Exclusion Criteria:

* Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment
* Patients unable or unwilling to use a computer or similar device will be excluded from enrollment.
* Patients will be excluded if they speak a language not supported by the Sound Success platform. Sound Success is available in English, Spanish, French, Italian, Dutch, Polish, and Danish.
BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.


Eligibility Criteria:
Inclusion criteria:

* Patients with early signs of dementia of Alzheimer Type
* Male and female patients with an age of at least 55 years
* Concomitant use of acetylcholinesterase inhibitors (AChEIs) is allowed but not required. Patients who are currently taking AChEIs are eligible as long as they have been using a stable dose for at least 3 months prior to screening and no change is foreseen for the duration of the study. This dose must be consistent with the product label in the concerned country. Patients who are not currently taking AChEIs but have taken them in the past are also eligible if AChEIs were stopped at least 3 months prior to screening.
* Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient and documented by the study investigator.
* Patients must have a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian)
* Further inclusion criteria apply

Exclusion criteria:

* Cognitive impairment or dementia with any etiology other than Alzheimer's Dementia (AD)
* Substantial concomitant cerebrovascular disease (defined by a history of a stroke / intracranial haemorrhagia) temporally related to the onset of worsening of cognitive impairment per investigator judgement
* Medical history or diagnosis of any of symptomatic and unstable/uncontrolled conditions per investigator judgement
* Patients receiving prescribed drugs for treatment of dementia of Alzheimer Type (other than Acetylcholine Esterase Inhibitors) at screening or within 3 months prior to screening
* Previous participation in investigational drug studies of dementia of Alzheimer's Type within three months prior to screening. Patients having received any active treatment in studies targeting disease modification of AD are excluded. Previous participation in studies with non-prescription medications, vitamins or other nutritional formulations is allowed.
* Clinically significant uncompensated hearing loss in the judgment of the investigator. Use of hearing aids is allowed.
* Further exclusion criteria apply
Medium-chain Triglyceride Oil Massage on Growth in Preterm

Aim: To explore the effect of medium-chain triglyceride (MCT) oil massage on growth in preterm infants.

Methods: This randomized controlled trial was conducted in the newborn center of a regional hospital in Taiwan. Preterm infants weighing between 1500 and 2000 g were recruited and randomly assigned to three groups: the MCT oil massage, massage alone and no massage groups. The massages were given three times per day for 7 consecutive days. Weight, length and head circumference were measured in the three groups at birth and on study days 1 to 7.


Eligibility Criteria:
Inclusion Criteria:

1. gestational age between 28 and 37 weeks;
2. weight between 1500 and 2000 g after enrollment;
3. medically stable condition;
4. ≥120 cc per day feeding.

Exclusion Criteria:

1. congenital anomalies;
2. skin disease;
3. requirement for mechanical ventilation;
4. requirement for O2 therapy;
5. presence of fracture.
Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

* Type 1 diabetes.