cyrilzakka/clinical-trials huggingface dataset:
The Use of Blood Biochemical Markers for Diagnostics of Heart Muscle Diseases

The aim of the study is to determine the analytical characteristics of the microRNA enzymatic immunoassay (miREIA) method and to determine various relations among miRNA biomarkers and heart failure (HF) with reduced ejection fraction(HFrEF).

The investigators assume that there are correlations between levels of selected miRNA and HFrEF. These correlations provide information to formulate pathophysiological conclusions, which will significantly contribute to early diagnostics and also the treatment of this disease.

Heart failure presents a significant diagnostic and treatment problem. The mortality in the Czech Republic related to this condition is high. The current treatment strategy consists of the administration of medication to patients, in order to attenuate the clinical manifestations of the disease and to influence the overall survival of patients suffering from this condition. Another treatment option is a mini-invasive procedure, with implantation of a pacemaker with biventricular stimulation, or transplantation of the heart. Despite these treatment options, the mortality of patients due to heart failure remains high, and new approaches are being studied for the diagnostics and treatment of heart failure. Factors that may play an important role in earlier diagnostics are miRNA. These molecules are located in the circulating blood. They are being described as suitable prognostic markers of heart failure, which may contribute to earlier diagnostics and bring a better understanding of processes going on in the human body.

In the study, the authors will take blood samples in order to analyze the presence of miRNA. These levels of miRNA will be compared with heart ultrasound parameters of HF patients and healthy control subjects.

Eligibility Criteria:
Inclusion criteria (patient group):

* left ventricle ejection fraction (EF LV) equal or less than 40%
* age between 18-80 years

Inclusion criteria (control group):

* normal EF LV (left ventricular ejection fraction)
* no structural cardiac abnormalities
* age between 18-80 years.

Exclusion criteria:

* recent myocardial infarction
* recent percutaneous coronary intervention (PCI)
* recent decompensation of chronic heart failure
* chronic kidney disease with need for haemodialysis
* creatin level over 450 umol/l
* signs of acute or chronic inflammation with CRP (C-reactive protein) over 20 mg/l
* patient with a known tumour
* history of cardiovascular disease
* diabetes mellitus
* severe liver and kidney disease
* BNP (brain natriuretic peptide) \> 250 pg/ml or NTproBNP \> 500 pg/ml for males and 750 pg/ml for females
* signs of acute or chronic inflammation with CRP over 20 mg/l
Biomarkers Derived From Adipose Tissue Useful for Diagnosis and Prognosis of Cardiovascular Risk (CVR) in Obese Patient

This study evaluates the relationship between the adipose tissue, as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Bariatric surgery induces a significant reduction in co-morbidities associated with obesity, such as Diabetes mellitus, dyslipidemia, liver disease, arterial hypertension, obstructive apnea and cardiovascular risk. However this does not happen in all obese patients, even when there is a weight reduction.

It is known that the adipose tissue is actively involved in synthesis of cytokines and its role in metabolic phenotypes has been suggested. It is possible that the intrinsic mechanisms of adipose tissue participate in several benefits observed in morbidly obese patients who undergo to an anti-obesity surgery.

So this study explores the involvement of adipose tissue as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old.
* Morbid obese patients candidates to bariatric surgery.

Exclusion Criteria:

* Second bariatric surgery
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm

The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO\|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to understand the nature of study and has provided written informed consent.
* Patient is willing and able to perform all follow up visits at the study site.
* Patient is willing and able to use the CardioMessenger® and accepts the BIOTRONIK Home Monitoring® concept.
* CRT-D is indicated according to the current ESC guidelines.
* De novo implantation with no pre-existing defibrillator or pacemaker system
* Patient is in sinus rhythm without history of persistent or permanent atrial fibrillation.
* Patient has no atrioventricular (AV) block II or III.
* Patient has no evidence of impaired sinus node function.
* Patient has no need for atrial stimulation, has a resting heart rate (HR) \> 40 b.p.m and achieves a peak HR ≥100 b.p.m even under intended dosage of HR lowering medication verified by an appropriate method as clinical routine examination within 3 months prior to enrollment
* NYHA class II or III
* Patient receives guideline-based optimized medical therapy for HF including heart-rate lowering medication at the time of enrollment

Exclusion Criteria:

* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in an interventional clinical investigation.
* Life-expectancy is less than 1 year.
* Patient has tachycardia-bradycardia syndrome
* Any standard contraindication for CRT-D
* Frequent premature ventricular contractions (PVC rate \> 5 %/h) examined within 3 months prior to enrollment by appropriate routine method (e.g. 24 h holter electrocardiogram)
Therapy of Atrial Flutter by Afib Ablation

Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a question, if both arrhythmias are different forms of a common electrical phenomenon with atrial fibrillation being the underlying clinical problem (6).

Current clinical and experimental studies confirm the close relationship between atrial flutter (AFlut) and atrial fibrillation (Afib). After initiation of Afib this may organize under special intrinsic conditions or due to antiarrhythmic medication to AFlut so Afib may be supposed the underlying arrhythmia. Therefore after successful ablation of AFlut this reentrant circuit is not longer possible and Afib persists. After new occurrence of Afib a long diagnostic and therapeutic marathon begins with AF ablation at the end of all therapeutic efforts. This double burden for the patient and the health system can probably be avoided by directly and effectively treating the underlying arrhythmia AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with- in 12-Channel-ECG documented atrial tachycardia suggestive of typical isthmus dependent atrial flutter
* \> 21 years

Exclusion Criteria:

* - AFL as secondary to an accessory pathway
* Antiarrhythmic treatment for AF
* AF
* Previous AF ablation
* Dilatation of left atrium \> 6 cm
* Cardiac surgery less \< 3 weeks
* Congenital heart disease
* Cardiac ischemia or coronary artery disease that needs intervention
* Life expectancy less than 2 years
Wound Dressings for Hidradenitis Suppurativa

The primary purpose of this research is to determine how the types of wound dressings affect quality of life for people with Hidradenitis Suppurativa (HS).


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age
* Diagnosed with Hidradenitis Suppurativa (all stages of disease) by Dermatologist
* Presence of at least one lesion with active drainage
* Willing and able to provide informed consent

Exclusion Criteria:

* Subjects younger than 18-years-old.
* Prisoners
* Pregnant or lactating women
* Adults unable to consent
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries

Muscle sprains of the back and neck are very common. In addition to pain and antiinflammatory medications the use of either cold or hot packs has been recommended. In the current study we will compare ice packs and heat packs to see which is more effective at relieving pain from back and neck sprains while in the Emergency Department.

as above

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients with acute neck or back pain who are able to consent and are in pain on arrival to Emergency Department.

Exclusion Criteria:

* Those unable or unwilling to consent, those with suspected fractures or neurologic deficits.
PKU EASY Microtabs Plus - Acceptability and Tolerance

PEMP-AT is a prospective, single-arm, open-label, 1-week acceptability study to evaluate PKU EASY Microtabs Plus for the dietary management of participants with phenylketonuria (PKU). Up to 10 participants aged 3 years and above will be recruited in a single-centre in the UK.

PKU is a rare inborn error of metabolism with a prevalence of 1 in 10,000 in the UK population. The mainstay of treatment for most individuals is dietary therapy with a strict protein-restricted diet. We propose to recruit children with a diagnosis of PKU aged 3 years and above.

The study product, PKU EASY Microtabs Plus is a food for special medical purposes (FSMP), as defined by the Delegated Act EU 2016/128, used for the dietary management of Phenylketonuria (PKU).

The study will be investigating the acceptability of PKU EASY Microtabs Plus, as defined by the Advisory Committee on Borderline Substances (ACBS). This includes the following:

participant adherence to recommended intakes gastrointestinal symptoms evaluations of palatability. Each participant will be on the study for 1 week.

The study consists of a 1 week period where participants introduce the study product into their diet. Gastrointestinal tolerance, compliance and product acceptability will be evaluated.

Data collection will be performed using paper data collection forms completed by the investigators at the baseline and end of study visits. Patients/parents/guardians, as appropriate, will also complete a brief daily questionnaire on each of the 7 study days. There will also be a questionnaire completed by the patient/parents/guardians over the course of the study, in relation to protein substitute intake, gastrointestinal tolerance, and product acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PKU requiring an appropriate protein substitute
* Subjects who are already taking an appropriate protein substitute and are willing to try the study product for 7 days
* Subjects aged 3 years and above
* Written informed consent obtained from subject or parent/legal guardian, depending on subject age

Exclusion Criteria:

* Presence of serious concurrent illness
* Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study, with the exception of sapropterin
* Any subject having taken antibiotics over the previous 2 weeks leading up to the study
* Subjects less than 3 years of age
Health Coaching for Patients Waiting for Hip or Knee Replacements

A randomised controlled feasibility study of a health coaching intervention targeting people on the waitlist for hip or knee replacement surgery with low patient activation.

Determine the feasibility of recruitment and retention to the trial. Evaluate the acceptability of research procedures and outcome measures. Explore the impact of trial participation through patient activation, self-reported health outcomes and interviews.

Eligibility Criteria:
Inclusion Criteria:

* On the waitlist for total hip or total knee replacement surgery
* PAM level 1 or 2

Exclusion Criteria:

* Current participation in care with a focus on self-management education
* PAM Level 3 or 4
Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

The purpose of this research is to study the efficacy and safety of AMG 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (HPT).


Eligibility Criteria:
Inclusion Criteria: - Completed one of the qualifying studies (i.e., patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism \[HPT\]; in particular parathyroid hormone \[PTH\], calcium and phosphorus levels in blood associated with kidney failure) - Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study Exclusion Criteria: - Pregnant or nursing females - Experienced a myocardial infarction within 3 months before day 1 - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device

It is hypothesized that performing VF measurements with a Virtual Reality headset using similar testing strategies as implemented in conventional perimeters, allow for a non-inferior quality in VF acquisitions. The results of this study will show if valid measurements of such devices in human subjects can be obtained.

The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.


Eligibility Criteria:
Written informed consent

Inclusion Criteria for normal visual field subjects:

* Cataract yes or no
* Age range 40 - 80 years- normal visual field (MD: \< +2 dB)
* Refractive error within ±5 dpt. spherical equivalent
* Astigmatism of \< -3 dpt.
* Visual acuity of ≥0.3 logMar (decimal ≥0.5)
* Experience in perimetry (history of at least one perimetry examination)
* False positive or negative errors each less than 20% in each examination

Inclusion Criteria for glaucomatous subjects:

* Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma
* Early to moderate visual field loss (MD: +2 to +12 dB)
* Refractive error within ±5 dpt. spherical equivalent
* Astigmatism of \< -3 dpt.
* Visual acuity of ≥0.3 logMar (decimal ≥0.5)
* Experience in perimetry (history of at least one perimetry examination)
* False positive or negative errors each less than 20% in each examination
* Cataract yes or no

Exclusion Criteria:

* Exclusion criteria are subjects younger than 40 and older than 80 years
* Inability to follow the procedure
* Insufficient knowledge of project language
* The history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
* Any history of epilepsy
Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients After COVID-19 in Comparison With Immunocompetent Patients

This is a prospective study analyzing the development of humoral immune response against SARS-Cov-2 in patients with previous Covid19: the aim is to compare the incidence, titration and evolution of IgG an IgM in a prospective cohort of liver transplant patients surviving to the first wave of Covid19, in comparison to not inmmunossupressed patients.

The liver transplant (HT) recipient population is more susceptible to infections than the general population. Few data are available regarding the incidence and clinical course of SARS-CoV-2 infection in this population, initially considered to be "high risk" regarding a possible higher incidence and severity of infection in these patients.

A prospective cohort of liver transplant recipient patients diagnosed with SARS-CoV-2 infection (Clinical Trials.gov Protocol Record HCB / 2020/0384) has been developed from SETH (Spanish Society for Liver Transplantation). This study aims to analyze the incidence and establish the clinical evolution of the infection in these patients. Initial data from the cohort, which includes 111 incidental cases diagnosed as of April 7, show a higher standardized incidence than the general population, but not higher mortality (data being published).

The chronic immunosuppression in t solid organ transplant patients could play a double role with respect to SARS-Cov-2 infection: on the one hand, it may condition a greater susceptibility and initial aggressiveness, in relation to itself viral effect, and in the other hand, it could protect by reducing the immune response that triggers the pulmonary and systemic inflammatory process.

After the initial Covid-19 outbreak, both in the general population and in immunosuppressed patients, the rate of specific IgM and IgG seroconversion against this coronavirus, and its protective capacity against reactivations or reinfections, are unknown. Therefore, it is a challenge for health organizations to identify the immune response in the population and to characterize its degree of protection, to adopt early measures to lessen the consequences of possible epidemic waves in the coming months.

Continuing with the prospective study of the cohort of liver transplant patients diagnosed with Covid-19 (SETH-Covid-19), already defined and composed of 91 living patients, the humoral immune response and its evolution in the first 12 months after initial infection. The cohort will incorporate the new incidental cases; A comparative study will be carried out with a contemporary cohort of non-immunosuppressed patients, controlled for age, gender and severity of the initial disease.

Eligibility Criteria:
Inclusion Criteria:

Patients recovered of covid 19 Informed Consent

Exclusion Criteria:

Chemotherapy on going Concomitant Autoimmune diseases
Intensive Arterial Pressure Control in Acute Coronary Syndrome

The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term.

the study compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.

Acute coronary syndrome is often associated with arterial pressure elevation which are deleterious for the heart and needs urgent intervention to lower the blood pressure to the required values, however there is no clear recommendations concerning the treatment intensity in this situation.

The investigators know that high arterial pressure increases the oxygen myocardial consumption and it is deleterious in acute coronary syndrome, so , it is logical to reduce intensively this pressure.

Eligibility Criteria:
Inclusion Criteria:

* Non-ST segment elevation Acute Coronary Syndrome

Exclusion Criteria:

* SBP under 90 mmHg or hemodynamic instability
* Complicated ACS (arrythmias, atrio-ventricular block, shock, tamponade...) or ST elevation myocardial infarction (STEMI)
* Patients with contraindication to nitrates and/or beta blockers
Feasibility and Added Value of the TRACMOTION Device for ESD

A single center non-randomized prospective clinical study, to evaluate the feasibility and added value of the CE-certified Tracmotion device in patients scheduled consecutively for ESD in the upper and lower gastrointestinal tract.

After ESD, the endoscopists' opinion will be evaluated with a short questionnaire on experience with the Tracmotion device. The pathology report will be checked for radicality and microscopic damage of the removed lesion.

Objective: The purpose of this study is to establish feasibility of the Tracmotion device for ESD and to define its added value during ESD in both upper and lower GI procedures, both in antegrade and in retroflex positions.

Study design: Single center prospective observational non-randomized clinical study.

Study population: A total of 20 consecutive cases scheduled for ESD will be included. Sample size calculation does not apply for this type of study. Patients already scheduled for ESD will undergo an ESD procedure as planned with the aid of the Tracmotion device. It is anticipated that the Tracmotion will provide superior traction and counter traction compared to off-label tools.

Intervention: Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device.

Main study parameters/endpoints:

Feasibility: procedure time, dissection speed, lesional damage (tearing or grasping injury to the mucosa on macroscopy and pathological review) Added value: subjective evaluation of the Tracmotion device by the performing endoscopist (contentment of use of Tracmotion, difference in procedure time, stability of, control of and accessibility to the lesion).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for endoscopic submucosal dissection (upper and lower gastrointestinal tract);
* Lesion is accessible with a therapeutic endoscope;
* Written informed consent;
* Age ≥18 years.

Exclusion Criteria:

* Coagulopathy (not corrected prior to endoscopic submucosal dissection);
* Participating in a different experimental drug/device trial in the previous 3 months.
National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)

PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.

PRO-RCC is designed as a multicenter cohort for all Dutch patients with localized RCC or metastatic renal cell carcinoma (mRCC). The clinical data collection is embedded in the framework of the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. The informed consent for PRO-RCC covers the online collection of PROMs and PREMS, data sharing and data linking with the NCR. PROMS entail Health-Related Quality of Life (HRQoL), symptom monitoring with optional ecological momentary assessment (EMA) of pain and fatigue, and optional return to work- and/or nutrition questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician. Importantly, participants may also consent to participation in a 'Trial within cohort' studies (TwiC). The TwiC design provides a method to perform (randomized) studies within the registry.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed patients with RCC or synchronous metastatic RCC
* metachronous metastasized RCC
* age \>18 years
* capable of understanding Dutch language

Exclusion Criteria:

* n/a