cyrilzakka/clinical-trials huggingface dataset:
Application of Citrate Dialysate in Chronic Haemodialysis

Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins.

It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins. Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* patients of either sex aged ≥ 18 years
* stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months
* patients without planned or predictable changes within diet, anticoagulation and medication regimen

Exclusion Criteria:

* pregnancy or lactation or woman in child bearing age without effective contraception
* planned surgeries or hospital stay within the next 9 weeks
* use of catheter as vascular access for dialysis
* severe comorbidities not allowing to follow the study protocol
* concomitant participation in another study
* previous participation in this study
Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression

This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Depression is a serious medical illness that has been associated with increased risk for heart disease and diabetes. Depression may negatively impact aspects of self-care that are required to effectively manage such long-term diseases. In depressed people who have heart disease and/or diabetes, treatment for depression appears to result in only limited improvements in depression symptoms and no improvements in heart disease and diabetes symptoms. An integrated treatment approach may be more effective in improving all three conditions. This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Participants in this single-blind study will be randomly assigned to take part in the case management intervention or receive usual care. All participants will attend 5 in-person study evaluation visits and receive 4 follow-up phone calls over 24 months. At each of the study visits, measurements of height, weight, waist size, and blood pressure will be taken. At study evaluations, blood and urine samples will also be taken. Participants will be asked not to eat for 8 hours before providing blood samples at 3 of the visits. During follow-up phone calls participants will answer various questions.

The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. Outcomes will be measured at Months 6, 12, 18, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes and/or heart disease
* Poor disease control (defined as an HbA1c level of at least 8.5%, blood pressure greater than 140/90 mm Hg, LDL cholesterol greater than 130 mg/dL)
* Diagnosis of major depressive disorder

Exclusion Criteria:

* History of psychosis
* At high risk for suicide
* Cognitive impairment
* Current alcohol or substance abuse disorder
* Does not own a telephone
* Currently seeking psychiatric care
* Pregnant or breastfeeding
* Currently enrolled in a Group Health Cooperative disease management program
* Terminal illness
* Plans to leave Group Health Cooperative in less than a year
* Does not speak English
Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

The proposed research project aims to investigate sarcopenic obesity (SO), a condition characterized by the combination of high body fat and low skeletal muscle mass, with a focus on muscle function. SO has been defined according to the ESPEN-EASO algorithm, and this study aims to evaluate its validity, exploring associations with circulating biomarkers and functional outcomes. By enrolling 75 subjects with SO and a control sample of 75 subjects with non-sarcopenic obesity, the primary objective of this study is to examine the consistency of the proposed diagnostic criteria with respect to circulating biomarkers and functional outcomes. Secondary objectives include the assessment of additional variables and the detailed profiling of SO subjects through questionnaires and multidimensional tests. The ethical aspect of the present study will be guaranteed through written informed consent and protection of privacy, respecting international regulatory standards. The investigators believe that this work provides significant contributions to the understanding of sarcopenic obesity and to the validation of diagnostic criteria, with possible implications for public health. The investigators are available for further clarifications and approvals required by the Ethics Committee.


Eligibility Criteria:
Inclusion Criteria:

* BMI equal more than 30
* Caucasians

Exclusion Criteria:

* any disease or medication that can significantly affect body composition (eg.malignant diseases in the last 5 years, autoimmune diseases, neurological diseases, syndromic obesity),
* level of physical activity more than 3 METS
* alcohol intake more than 140g/wk for M and 70g/wk for F
* participation in a weight-reducing program (last 3 months),
* impossibility to perform DXA exam
* pregnancy and breast-feeding.
Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients

Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
* Completion of the IM HBV vaccine series in infancy.
* HBsAb titer of \<10mIU/mL at the time of enrollment.

Exclusion Criteria:

* Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathioprine, 6-MP, steroids).
* Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Wedge Resection or Parietal Pleurectomy for the Treatment of Recurrent Pneumothorax (WOPP)

Primary spontaneous pneumothoraces (PSP) represent a significant public health problem, occurring in young healthy subjects without pre-existing lung disease or precedent medical intervention or trauma with a reported incidence of up to 18-28/100 000 per year. PSP treatment often requires thoracic surgery to restore lung expansion and to prevent de novo lung collapse. Despite the presence of elaborated guidelines by the British Thoracic Society (BTS) postulating apical wedge resection of the lung and total parietal pleurectomy (WRPP), the majority of German hospitals gathered experience especially in limiting surgery to cost-saving partial apical parietal pleurectomy or yet apical pleural abrasion (PP). Until today, hardly any reliable data exist to analyze and compare the varying treatment approaches regarding efficacy and efficiency. In this randomized, multi-centric clinical trial, both treatment approaches will be compared. For this purpose, candidates for surgery will be randomized into one of the two treatment groups after informed consent has been obtained. Patients will be followed for 2 years by the participating centres to be able to evaluate the long-term effect of the surgical interventions.

The trial will be conducted at the major thoracic surgery units in Germany. Each centre can include patients on the basis of the presence of a PSP and the inclusion and exclusion criteria.

After informed consent has been obtained from the study participants, each has to fill out the standardized short-form health survey (SF-36) questionnaire and the visual analogue scale (VAS) to determine baseline parameters for the (current) state of health and pain level.Randomization into the two interventional groups is carried out before surgery.

Patients are operated according to good clinical practice either by pleurectomy alone (PP) or total parietal pleurectomy with apical wedge resection of the pulmonary apex (WRPP). Procedure related parameters (like operation time, applied suture materials including staplers) are documented.

The postoperative care is subject to each participating centre's standards. The postoperative course is evaluated (mortality, morbidity, duration of tube drainage, re-interventions or operations, length of stay, need for blood substitutions).

To evaluate the long term effect of the surgical intervention, all study participants are followed for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* recurrence of a primary pneumothorax
* persistent primary pneumothorax
* patient preference (in primary events)

Exclusion Criteria:

* presence of a pulmonal fistula
* underlying lung disease
* previous thoracic surgery (except tube thoracostomy)
* previous pleurodesis
* conversion thoracotomy
Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)

This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old at the time of their first (index) injection of brolucizumab.
* Had documented neovascular age-related macular degeneration (nAMD) on or within 3 years before the index injection.
* Used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection.

Exclusion Criteria:

* Had received any other anti-VEGF agent between the index injection and 12-month follow-up.
* Lacked information about the laterality of disease at the time of the index injection.
* Lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).
Impact of High-dose Pretreatment of Rosuvastatin in Patients With Acute Coronary Syndrome Following Off-pump Coronary Artery Bypass: Results From the HIROP-ACS (HIgh-dose Pretreatment of Rosuvastatin During Off-Pump Coronary Bypass in Acute Coronary Syndrome) Study

Periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.

-Objective: to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in patients with stable angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary syndrome.

Study design

* Prospective, double-blinded, single-center study of each 117 subjects enrolled
* Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled preoperatively.
* Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B) Placebo (n=117).
* The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a total
* All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be compared at 30 days and 2 years postoperatively between two groups


Eligibility Criteria:
Inclusion Criteria:

* The presence of acute coronary syndrome, including unstable angina, acute non-ST elevation myocardial infarction
* Age of 19 years or older
* A need for isolated surgical myocardial revascularization
* Patients with signed informed consent

Exclusion Criteria:

* Patients with combined surgery with coronary bypass grafting
* On-pump conversion
* Patients with any increase in liver enzymes
* Patients with history of liver or muscle disease.
* Patients with moderate renal dysfunction (creatinine\>2.0mg/dl) or need for dialysis
* Re-do surgery
* Urgent/emergent surgery
Evaluation of Artificial Intelligence Models for Diagnosis of Anterior Open Bite Malocclusion

Building artificial intelligence models for diagnosis of anterior open bite malocclusion

The study aims at creating artificial intelligence models, with the input being the pre-treatment photographs and radiographs of open bite patients that are routinely taken for diagnosis and treatment planning. The output of the AI model will be the type and phenotype of anterior open bite. The photographs and radiographs with highest quality will be arranged in certain standardized templates to facilitate the machine learning process.

Eligibility Criteria:
Inclusion Criteria:

* anterior open bite

Exclusion Criteria:

* craniofacial syndromes, previous orthodontic treatment, poor quality records
Comparison of Clinical Outcomes of Toric Intraocular Lens

This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.

In cataract surgery, after phacoemulsification, intraocular lens should be implanted for patient's better visual acuity. When patient has large amount of corneal astigmatism, toric intraocular lens are recommended to correct the preexisting astigmatism.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface)

Exclusion Criteria:

* Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery
Immune Cell Subgroups in Covid 19 Patients

COVID-19, spreading rapidly all over the world, causes serious morbidity and mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. It is noteworthy that it causes lymphopenia in patients. In studies conducted, the effects of Covid-19 on the immune system were evaluated with limited parameters. In addition, no study evaluating the effect of this disease on the immune system has been published in our country.

The causative agent of coronavirus 2019 (COVID-19) disease, which started in Wuhan province of China in December 2019, was severe acute respiratory failure syndrome coronavirus 2 (SARS-CoV-2), which quickly spread all over the world and caused a pandemic. COVID-19 can cause death with symptoms such as fever, cough, muscle pain, shortness of breath, and pneumonia (1). Pulmonary pathology of COVID-19 is diffuse alveolar damage, focal reactive hyperplasia of pneumocytes with patchy inflammatory cells, intravascular thrombosis, monocyte, macrophage and lymphocyte infiltration into pulmonary spaces. Severe infiltration of pulmonary tissue affects alveolar gas exchange. In addition, cardiovascular morbidity, tachyarrhythmia and thromboembolic events are observed in 1/5 of the hospitalized patients with troponin elevation, which is closely related to mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure.

It is noteworthy that it causes lymphopenia in patients. In the studies conducted, the effects of Covid-19 on the immune system and the determination of cell subgroups were performed with limited parameters. No studies have been conducted on PDL-1, one of the immune control points. In addition, no study evaluating the effect of this disease on the immune system with wide parameters has been published in our country.

We aimed to study CD3 (+) lymphocytes, CD4 (+) lymphocytes, CD 8 (+) lymphocytes, CD 3(-)/CD16 (+) NK cell ratio, CD14 (+) lymphocytes, and HLA-DR positivity on CD14 (+) cells at Covid-19 and healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Covid 19 PCR (+) results

Exclusion Criteria:

* Cancer Patients
* Patients with known immunodeficiency
* Pregnancy
Community Preparedness for Outbreak Response and Readiness for Ebola Vaccination in Liberia

This community-based mixed methods study intends to identify, explore, and assess the determinants of community preparedness for outbreak situations, including acceptance for Ebola vaccines.

This community-based study intends to identify, explore, and assess the determinants of community preparedness for outbreak situations and acceptance for the administration of Ebola vaccination. The investigators will conduct an anthropologically driven mixed methods study design that comprises both qualitative and quantitative research methods for the successful implementation of this community-based study. The investigators will conduct structured interviews with community members and local responders to broadly assess and understand the perspectives regarding appropriate strategies previously employed to effectively support community preparedness during outbreak response and also to broadly access and understand appropriate strategies previously employed to effectively support community acceptance for Ebola vaccines, respectively. Learning from the experiences of local voices produces globally emergent systems that are trusted, reliable and sustainable.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Community Leaders
* Community Members
* Reside in 1 of 3 highly prevalent counties
* Participated actively in EVD outbreaks related activities
* Documented roles recognized by the Incident Management System

Exclusion Criteria:

* Not Adults
* Does not reside in any of the 3 highly prevalent counties
* Did not actively participate in the EVD outbreak response related activities
* Roles not documented by the Incident Management System
Leuven Tolerogenic Protocol for Intestinal Transplantation

An immunomodulatory protocol, experimentally-proven to promote T-regulatory dependent graft protective mechanisms was applied in a clinical cohort of 13 intestinal transplant recipients to activate - in a protolerogenic environment - T-regulatory cells.

This protocol is the standard of care in the investigators intestinal transplant programme since the first intestinal transplant was performed in october 2000.

The LP is a 4-step approach that aims to upregulate T-regulatory cells (T-Regs) by directly stimulating their development and removing stimuli that could suppress them, eventually creating an environment favorable for graft acceptance. This protocol has been based upon preclinical research perormfed in the investigators lab and has been implemented as standard of care since the inception of the clinical programma in 2000. Patients gave informed consent for Donor Specific Blood Transfusion. Ethical approval for collection of additional blood samples was granted by the local ethical committee (s56862).

Step 1. Donor-specific blood transfusion (DSBT). 400 mL of whole blood was collected from the donor at the time of procurement and was transfused systemically in the recipient prior to reperfusion.

Step 2. Avoiding high-dose steroids. After Intestinal Transplantation, only 16 mg of medrol was administered and tapered towards 4 mg in 3 to 6 months post-Tx, similar to the liver Tx protocol.

Step 3. Avoiding high-dose calcineurin inhibitors (tacrolimus). Initial levels of 15 ng/ml were tapered -within 3 to 6 months- to 5 ng/mL or less for liver-containing grafts and 6 to 8 ng/mL for isolated intestinal grafts.

Step 4. Maintaining mucosal integrity and reducing ischemia reperfusion injury, inflammation, and endotoxin translocation. This was obtained by selecting perfect (ischemia-free) donors (\<50y, absence of significant hypotension, vasopressor requirement and cardiac arrest); pretreating donors with selective bowel decontamination and glutamine; gentle manipulations of the organs during donor and recipient surgery; aiming for short cold and warm ischemic times (5h and 30' respectively). Bowel decontamination consists of Nilstat, Tobramycine and Colimycine administered by a nasogastric tube and continued posttransplant during three months. Glutamine is supplemented parenterally (Dipeptiven Kabi Fresenius) and enterally (Alitracq) to donors and continued posttransplant.

Eligibility Criteria:
Inclusion Criteria:

* all patients awaiting intestinal transplantation

Exclusion Criteria:

* living donation
The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters

This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.

This is a double blinded Randomized controoled trial of 30 days duration. The trial device is the Uroshield, SAW device which is an externally applied device attached to the external portion of the urinary catheter.

Subjects will be randomized to a control group and the treatment group. The control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham UroShield device. The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device.

At baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. These numbers will be evaluated to see if there is a difference between the active and sham devices.

Eligibility Criteria:
Inclusion Criteria:

* Currently being treated with an indwelling urinary catheter for at least 30 days.
* Ability to sign informed consent or have someone authorized to sign informed consent.

Exclusion Criteria:

* Currently being treated for an active Urinary Tract infection.
* Previous treatment with Surface Acoustic Waves.
Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease

The purpose of this study is to determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion of any patient (\< 18 year-old) with congenital heart disease undergoing one or more cardiac catheterization

Exclusion Criteria:

* Exclusion of patients with any type of thyroid dissease