cyrilzakka/clinical-trials huggingface dataset:
Studies Investigating Co-morbidities Aggravating Heart Failure

SICA-HF is a prospective, multicentre, multinational, longitudinal, pathophysiological evaluation study, which is being conducted in 11 centres across six countries. SICA-HF receives funding from the European commission's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 241558 (SICA-HF) and from the Russian Ministry of Science and Education within the file transfer protocol "R\&D in priority fields of the S\&T complex of Russia 2007-2012" under state contract number 02.527.11.0007. The aim of SICA-HF is to provide detailed characteristics of co-morbidities of heart failure at baseline and over time, particularly with regards to obesity, cachexia, and type 2 diabetes.

SICA-HF, consisting of outstanding European heart failure clinicians and basic researchers, has accomplished to provide a common platform for the two different research teams. All partners of SICA-HF recruited more than 1462 patients with chronic heart failure, 199 patients with type 2 diabetes without heart failure, and 173 healthy control subjects. Thus, during the last year, a cumulative 91.4% of the target value was achieved for patients with chronic heart failure, 66.3% of the target value for diabetic controls, and 115.3% and thus over-achieving for healthy subjects. The data of all participating centers were collected and entered into the central database. As of this writing, 1469 of all chronic heart failure patients' visits, 255 of diabetic controls' visits, and 167 healthy controls' visits have been entered into the online database. In total, 171 patients have been reported to be deceased; the total number of hospitalizations is 2232.

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of heart failure;
* Objective evidence of cardiac dysfunctions as evidenced by at least ONE of the following:

  * left ventricular ejection fraction ≤ 40%;
  * left atrial dimension \>4.0 cm (or \>2.5 cm/m in height)
  * NT-proBNP \>400 pg/ml \[\>47.3 pmol/l\] (or BNP \>150 pg/ml)
* Current treatment with loop diuretics;
* Age \>18 years;
* Willingness to provide informed consent

Exclusion criteria:

* Congenital heart disease;
* Any life-threatening disease other than heart failure;
* Active malignancy of any type, or history of a malignancy within previous 5 years;
* Previous heart transplantation;
* Intra-venous therapy for heart failure given within the previous 72 hours;
* Severe neuro-muscular disease;
* History of unstable angina, myocardial infarction or stroke within 3 months prior to the study;
* Pregnancy;
* Treatment with immunosuppressive therapy, e.g. steroids for rheumatoid arthritis or obstructive lung disease;
* Significant renal dysfunction, defined as serum creatinine \>250 μmol/L \[\>2.8 mg/dL\];
* Severe liver disease, defined as any liver function tests \>3 times the upper limit of normal;
* Unable to understand and comply with protocol or to give informed consent.
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery

NOTE regarding reason for study termination:

A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor.

A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and over that require open abdominal surgery

Exclusion Criteria:

* Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy
Antidepressant Decision Aid for Major Depressive Disorder Patients

The purpose of this study is to determine whether Antidepressant Decision Aid for Major Depressive Disorder is feasible and effective in involving patients in the decision-making process when initiating pharmacotherapy.

To examine the ability of the patient decision aid to enhance shared decision making and preparedness to make decisions pertaining to antidepressant therapy. The research team has systematically developed an Antidepressant Decision Aid for Major depressive disorder patients (ADAM) according to the International Patient Decision Aids Standards (IPDAS) and the Ottawa Decision Support Framework. This is a posttest-only study with nonequivalent groups to evaluate the effect of the antidepressant decision aid on patient and physician perception of shared decision making as well as patient preparedness for making pharmacotherapeutic decisions compared usual care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Major Depressive Disorder (MDD)
* No psychotic symptoms
* Based on psychiatrist's clinical judgement currently in need for antidepressant treatment.
* Functional English literacy and language skills (to use the decision aid and fill out the questionnaires)
* Provides consent

Exclusion Criteria:

* Psychosis
* Communication barriers (visual impairment, language barrier)
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart

Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 50-80
* On finasteride for no less than 12 months
* Willing to undergo all necessary test in the 12 month evaluation

Exclusion Criteria:

* History of medication non-compliance
* Unwillingness to undergo/tolerate 2 blood draws
* Unwillingness to tolerate/undergo 2 TRUSP
Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias

The purpose of this study is to investigate non-linear heart rate variability indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients who will have cardiac surgery
* The patient must be mentally able and willing to participate in the study
* Male or female patients over the age of 18

Exclusion Criteria:

* Patients with major renal, hepatic, respiratory, or cerebral dysfunction
* Patients with atrial fibrillation or other forms of sinus node dysfunction
* Patients requiring continuous artificial pacing
* Patients with significant congenital heart disease with or without arrhythmias
* Patients on Intra-Aortic Balloon Pump
* Patients experiencing cardiac emergencies or undergoing cardiac salvage operations
Safety of Aerobic Exercise in Acute Heart Failure

This project deals with exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).

All of the subjects performed an individualized clinical evaluation right after hospital admission on day 1 (D1) by the cardiologist and physiotherapis involved in the study. Pulmonary function tests (spirometry), blood sample (brain natriuretic peptide \[NT-proBNP\] and high sensitive C-reactive protein \[hs-CRP\]), six-minute walk test (6MWT), and maximal inspiratory pressure (MIP) test were performed.

After the clinical tests were performed, the patients were randomized into three groups, and all received standard medical treatment.

The control group (CTL) received medical treatment and did not perform aerobic exercise training; the ET+NIV group performed aerobic exercise training associated with NIV once a day, for 8 consecutive days; and the ET+Sham group performed aerobic exercise with placebo NIV once a day, for 8 consecutive days. The ET+NIV and ET+Sham groups also received medical treatment.

After eight consecutive days, all of the patients underwent a new clinical evaluation (D10). After D10, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of acute HF; previous Doppler echocardiography with left ventricle ejection fraction (LVEF) \<30%, and NYHA Class IV.

Exclusion Criteria:

* unstable angina, complex cardiac arrhythmias, pacemaker, cardiac resynchronization therapy or left ventricle assist device, myocardial infarction within the previous 12 months, oxygen saturation by pulse oximetry (SpO2) at rest \< 88% without oxygen supplementation, acute pulmonary edema with clinical indications for mechanical ventilation
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

This is an observational, retrospective cohort study, using the UK PBC registry, comparing patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment and were treated with obeticholic acid (OCA) to patients with PBC who failed UDCA treatment and were not treated with second-line therapy. The study is designed to evaluate the effectiveness of OCA. All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria will be considered for this study.


Eligibility Criteria:
Key Inclusion Criteria:

1. Definite or probable PBC diagnosis
2. UDCA failure
3. Age ≥18 years at the index date
4. Evaluable data for at least 12 months before the index date (inclusive)

Key Exclusion Criteria:

1. History or presence of other concomitant liver diseases
2. Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
3. History of liver transplant
4. Evidence of OCA, fenofibrate, or bezafibrate use
5. History or presence of hepatic decompensating events
6. Participation in a clinical trial for a PBC medication
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure

The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.

Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
* Weight not less than 40 kilograms
* Not listed for organ transplant, but no medical contraindications for transplant

Exclusion Criteria:

* Listed for organ transplant at stud entry
* History of jaundice for greater than 28 days at screening
* Liver dysfunction due to trauma
* Concomitant serious disease
Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study

Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. It is likely that patients on haemodialysis will be amongst the first people to be offered vaccination against COVID-19 when they become available. While any vaccines offered to these patients will be safe to receive, the effectiveness of the vaccines at giving immunity to being infected with COVID-19 are not known as they have not been explicitly tested in patients on haemodialysis. This study will involve having 3 blood tests to test for an antibody response following vaccination for COVID-19. The first will be 1 month after the first vaccination dose to look at the initial antibody response and the second and third will be 1 month and 6 months after the second vaccination dose.

Patients with end stage kidney disease (ESKD) on haemodialysis are more likely to suffer poorer outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This is likely to be because these patients have higher levels of co-morbid diseases and they are relatively immunosuppressed due to the effects of advanced kidney disease. The humoral response against common viral vaccination is known to be blunted in patients with ESKD and there are data to suggest seroconversion following infection with COVID-19 is blunted in patients with kidney disease. A successful programme of vaccination will undoubtedly improve outcomes for patients on haemodialysis, but vaccine testing programmes have not included patients with ESKD. Whilst initial press-coverage of the efficacy of vaccines which are available for use is promising, they are untested in patients on haemodialysis who are known to be relatively immunosuppressed as a result of their renal disease and as such the efficacy for this patient group is not known.

This study will phenotype the IgG antibody response to vaccination for COVID-19 in 100 patients on haemodialysis compared to 50 healthy volunteers. Antibody testing will be conducted at 1 month post first vaccination dose and 1 month and 6 months post second vaccination dose. This will give crucial information as to the efficacy of the vaccine and inform possible requirements for re-vaccination.

This study will:

1. Phenotype the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 in patients on haemodialysis
2. Compare the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 between patients on haemodialysis and healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* End stage kidney disease on haemodialysis
* Able and willing to give informed consent
* Have completed or due to complete vaccination against COVID-19

Exclusion Criteria:

* Acute kidney injury requiring temporary haemodialysis
* Unable to give informed consent
* Pregnancy
Comparison of Efficacy of Intralesional Triamcinolone Injection and Clobetasol Propionate Ointment for Psoriatic Nails

Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of psoriatic nails is using topical high- potent steroids however topical steroids are limited their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of such a treatment can lead to skin atrophy and report in the case of "Disappearing digits". Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory results without any serious permanent adverse effects. At present, there is no comparison study between intralesional steroid and ultrapotent topical steroid for the treatment of psoriatic nails.

The purpose of the study is to evaluate the efficacy and safety of intralesional triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.

Psoriasis is a chronic inflammatory disorder. The nails involvement has been reported up to 40% of psoriatic patients. Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of psoriatic nails is using topical high- potent steroids however topical steroids are limited their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of such a treatment can lead to skin atrophy and report in the case of "Disappearing digits". Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory results without any serious permanent adverse effects. At present, there is no comparison study between intralesional steroid and ultrapotent topical steroid for the treatment of psoriatic nails.

The purpose of the study is to evaluate the efficacy and safety of intralesional triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged over 18 years old who have at least 3 psoriatic finger nails resembly severity

Exclusion Criteria:

1. Patients are receiving the systemic therapy of psoriasis
2. Patients discontinued the systemic therapy less than 3 months and topical therapy less than 1 month
3. Positive results for the microscopic study of fungus in finger nails
4. History of steroids or EMLA allergy
5. Pregnancy or nursing
6. Any skin infection at the site of the treatment
7. Human immunodeficiency virus subjects
8. History of malignancy or during the treatment of malignancy
9. Patients who have psychological disorder
10. Patients who have bleeding disorder or receiving anticoagulation drugs
The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple Sclerosis

The primary goal of this research is to study the prevalence of the wearing-off effect and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab with the use of questionnaires. Furthermore, the goal is to study whether patients receiving extended dosing of ocrelizumab experience more wearing-off symptoms or adverse events in general. Finally, we would like to extend knowledge on wearing-off symptoms in general.

Ocrelizumab is a monoclonal antibody very effective for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis. Ocrelizumab is usually administered intravenous every six months. Natalizumab is another type of treatment used for relapsing-remitting multiple sclerosis and is administered every four weeks. Often patients report MS-related symptoms just prior to their next infusion such as fatigue, coordination problems or motor problems, the so-called wearing-off phenomenon. The exact etiology of this phenomenon remains unknown. Although not studied before, patients do report similar symptoms when using ocrelizumab. Furthermore, because of the COVID-19 pandemic, some patients receive extended dosing of ocrelizumab based on b-cell count. Whether this can increase wearing-off symptoms is unknown.

The goal of this research is to study the prevalence of wearing-off symptoms and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab. All patients using ocrelizumab during one year or more that provided written informed consent to participate in the study will be asked to complete three questionnaires before or during their next treatment with ocrelizumab. The questionnaires that will be used are the MSIS-29, the treatment satisfaction questionnaire and a questionnaire about wearing-off symptoms. Exact weight of the participants will be measured. Information about age, gender, date of diagnosis, start date of ocrelizumab, clinical and radiological disease activity, EDSS score, b-cell count and the biomarker neurofilament light will be extracted from the patient files. After two weeks, participants receive two additional digital questionnaires, the MSIS-29 and a follow-up questionnaire about wearing-off symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis multiple sclerosis
* Use of ocrelizumab as a treatment for multiple sclerosis for a minimum of one year

Exclusion Criteria:

* Unable to answer questionnaires in Dutch
* Different infusion protocol during the previous ocrelizumab infusion (e.g. 300 mg of ocrelizumab instead of 600 mg).
The Tobramycin Study

Evaluate if tobramycin given once a day is at least as efficacious as the traditional tobramycin given three times a day, given with penicillin G, til patients with febrile neutropenia.

Prospective randomized Norwegian multicenter clinical trial (11 hospitals) comparing tobramycin given once a day (new regimen) vs. three times a day (current regimen), with penicillin G, to cancer patients with febrile neutropenia. Tobramycin half life and postantibiotic effect is at best 12 hours. It has been questioned if tobramycin once a day is safe in patients with low levels of granulocytes when it is given with a drug like penicillin G which is not covering Gram-negative rods. Treatment of febrile neutropenia with penicillin G and an aminoglycoside is standard of care in Norway, and it is probably a regimen that is promoting antimicrobial resistance less than a broad spectrum beta-lactam.

Cancer patients 16-70 with febrile neutropenia and signed informed consent could be randomized. Exclusion criteria were allergy to study medications, increased creatinine/renal failure, massive ascites, multiple myeloma, treatment with cis-platinum, recent therapy with aminoglycoside (4 weeks) or other antibiotics (4 days), hemodynamically unstable patients, pregnant and nursing patients.

Patients were stratified into three groups: Leukemia patients receiving intensive chemotherapy, lymphoma patients receiving high dose chemotherapy with autologous stem-cell support and other cancer patients.

Patients were randomized to either tobramycin once or three times a day. Once the patient was randomized and the first antibiotic dose was given, further antibiotic therapy was up to the patient's doctor's discretion (not blinded). Everybody received tobramycin 6 mg/kg/day and penicillin 5 mill. IE four times a day.

The patients were followed until all antibiotic therapy was terminated. Clinical condition and laboratory test results at time of randomization (new fever) was registered. Response to therapy, reason for modification of therapy, mortality, duration of neutropenia, maximum creatinine level, tobramycin serum concentrations, microbiological findings and total antibiotic consumption were registered.

After external monitoring of all the data the results are currently being made up and will be available for publication in 2006.

This trial has been conducted independently of the pharmaceutical industry. Grants have been received from The Norwegian Radium Hospital research fund, The Regional Health Authorities and The Norwegian Society for Infectious Diseases.

Eligibility Criteria:
Febrile neutropenia Cancer Adult (16-70) Signed informed consent