cyrilzakka/clinical-trials huggingface dataset:
National Cohort of Patients Co-infected with Hepatitis B and Delta Viruses

This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.

This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status:

* Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months;
* Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.

Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:

* Samples for the biobank,
* Self-administered questionnaires.

In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Presenting a chronic HDV infection (positive serology),
* Who gave his written informed consent before any intervention and the day of inclusion at the latest,
* Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).

Exclusion Criteria:

* Patient participating in another biomedical research with an exclusion period ongoing at inclusion,
* Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).
* Patients with predictable difficulties of follow-up according to the investigator.
Japanese Catheter Ablation Registry

Japanese Cather Ablation (J-AB) Registry is a voluntary nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The objectives of this registry are to observe and describe developments in the catheter ablation treatment of arrhythmia in Japan and to provide reliable information on the type of activity performed and the facilities available in Japanese arrhythmia units.

Japanese Cather Ablation (J-AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center.

This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system. Detailed data collection including antiarrhythmic medication is also performed at every September. The acute success rate at discharge and the complications associated with ablation procedure will be collected in all cases. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with catheter ablation in Japan

Exclusion Criteria:

* Patients who refused to consent
The Effect of Dan-shen Extract On Lipoprotein Associated PHospholipase A2 Levels IN Patients With Stable Angina Pectoris

This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will assess the effect of DanshenDuofensuanyan\[Danshen (a kind of Chinese herbal drug) extract\] treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina pectoris.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18 years-75 years;
2. Written informed consent;
3. Patients with a clinical diagnosis of chronic stable angina, which fulfil one of the following conditions:

   1. Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes
   2. a history of myocardial infarction and ST-T changes,
   3. stenosis of more than 50 % in at least one major epicardial coronary artery, as shown by coronary angiography or computed tomography angiography,
   4. Coronary heart disease confirmed by radionuclide angiocardiography;
4. Patients with moderate angina pectoris, which is defined as Grade II or III on the Canadian Cardiovascular Society Angina Grading Scale.

Exclusion Criteria:

1. Patients with severe complications that would complicate the condition, as assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral haemorrhage.
2. Patients who were angina-free during the run-in period without taking any drug.
3. Patients who experienced myocardial infarction or who were classified as Grade IV on the Canadian Cardiovascular Society Angina Grading Scale within the preceding 3 months.
4. Patients with chest pain that is caused by any other disease (e.g., acute myocardial infarction, severe neurosis, menopausal syndrome or hyperthyroidism).
5. Patients with a history of drug-induced bleeding or a history of bleeding caused by warfarin.
6. Patients with a history of haematopoietic disorder.
7. Patients who have had surgery within the previous 4 weeks or who have a haemorrhagic tendency.
8. Women who are pregnant or lactating or who have a positive pregnancy test, or women who have a menstrual period at baseline.
9. Patients who are participating in other trials or who have participated in other trials within the past 3 months.
10. Patients with a history of allergy or with a known or suspected allergy to the study drug.
11. Patients with a known or suspected history of alcohol or drug abuse within the past 2 years.
12. Patients with a mental disorder.
13. Family members or relatives of the study centre staff.
14. Inability to adhere to study procedures
Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery

Postoperative opioid-centric pain management strategies in obese patients are accompanied by the possible development of; opioid-induced ventilatory impairment (OIVI) and hypoxemia. This presents as sedation and respiratory depression, combined with upper airway obstruction and hypercapnia. If it remains undetected and untreated, it can result in increased perioperative morbidity and mortality.Thus, an increased interest in the use of non-opioid analgesic adjuncts has been prompted.

Intra-operative intravenous lidocaine infusion has analgesic, anti-inflammatory, anti-hyperalgesic, opioid-sparing effects with an enhanced recovery after surgery (ERAS) profile. Its postoperative analgesia may last after reduction of its plasma concentration. So, lidocaine could be a good alternative in bariatric surgery.

Lidocaine has been studied as part of an opioid-free multimodal analgesia in morbidly obese patients. Also, its use in bariatric surgery showed a decrease in postoperative opioid use and improvement in the quality of recovery.

compare the postoperative analgesic effect of intraoperative lidocaine infusion (Study group) used as a sole analgesic agent, to the intraoperative intravenous morphine (Control group) in laparoscopic gastric bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I- II
* body mass index (BMI) ˃ 35
* scheduled to undergo laparoscopic gastric bypass

Exclusion Criteria:

* Patients' refusal
* hypersensitivity to the study medications
* patients with known history of; hepatic disease, renal dysfunction
* severe renal impairment (eGFR \<30ml/min/1.73m2)
* heart failure; left ventricular ejection fraction than 35%
* any cardiac dysrhythmias; Adam-Stokes syndrome; Wolff- Parkinson-White syndrome, atrio-ventricular block with heart rate below 50 bpm
* chronic pain
* concomitantly taking beta blocking drugs •substance abuse disorder
* chronic opioid use.
Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients

Since the beginning of the SARS-CoV-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at Hospital do Rim have been infected. The overall lethality rate was 24%, reaching 53% among those over 70 years old. Among the survivors, there is also a high incidence of renal dysfunction with loss of the renal graft and definitive return to dialysis. Patients receiving pharmacological immunosuppression, including transplant recipients, have not been included in the studies carried out to date. In addition, kidney transplant recipients may have reduced vaccine responses compared to the general population. The severity, the high incidence of renal dysfunction and loss of renal graft, and the high lethality associated with COVD-19 justify the investigation of the epidemiological impact and immunogenicity of the vaccine against SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

1. Adults over 18 years old;
2. Time after transplantation greater than 3 months;
3. Time after treatment with anti-thymocyte globulin longer than 4 weeks;
4. Able and willing (in the investigator's opinion) to comply with all study requirements;
5. Provide written informed consent

Exclusion Criteria:

1. Planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination;
2. Prior receipt of an experimental or authorized vaccine with the possibility of impacting the interpretation of the study data (for example, vectorized vaccines by Adenovirus, any vaccines against coronavirus);
3. Administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine;
4. Any history of angioedema or anaphylaxis;
5. Pregnancy, lactation or willingness / intention to become pregnant during the study;
6. Diagnosis or current treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ);
7. History of severe psychiatric illness that possibly affects your participation in the study;
8. Hemorrhagic disorder (eg, factor deficiency, coagulopathy or platelet disorder) or a previous history of significant bleeding or hematoma after IM injections or venipuncture;
9. Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban);
10. Current suspected or known addiction to alcohol or drugs.
A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol

New strategy to improve the outcomes in patients with HCC and acute variceal bleeding. NSBB added to endoscopic ligation may further reduce rebleeding in cirrhotic patients.

Gastroesophageal vaiceal bleeding is a major complication of portal hypertension. Gastroesophageal variceal bleeding is characteristic of high rebleeding rate and mortality. Thanks to the recent advance of treatment including immediate vasoactive agents (such as somatostatin and vasopressin analogue for acute bleeding), non-selective beta-blocker (NSBB) for prevention of bleeding, prophylactic antibiotics, endoscopic variceal ligation, endoscopic cyanoacrylate injection , combination treatment and general improvement of care for patients with acute variceal bleeding, the rebleeding rate and mortality has a marked reduction. However, hepatocellular carcinoma (HCC) is a distinct group characteristic of very poor prognosis in patients in portal hypertensive patients when compared to those of liver cirrhosis only. Therefore it needs to specially clarify their treatment strategy, particularly in Taiwan, a highly prevalent area of HCC.

In patients of HCC presenting acute variceal bleeding, the rebleeding is around 50% doubled that of patients with cirrhosis only and bleeding mortality also more than 50%. The trend is not changed even after introduction of immediate use of vasoactive agents and endoscopic ligation. The poor outcome is because that HCC patients usually have arterioporal shunting or portal vein thrombosis and higher portal pressure. Moreover, their liver function deteriorated faster. Both high portal pressure and poor liver function are major determinant of hemostatic outcomes. Therefore, it is important to find a new strategy to improve the outcomes in patients with HCC and acute variceal bleeding.NSBB added to endoscopic ligation may further reduce rebleeding in cirrhotic patients. However, whether the hypotensive effect of NSBB is adequate to prevent rebleeding in patients with HCC who usually has higher portal pressure in not known. In addition, concomitant rapid deterioration of liver function might also dampen NSBB effects. Furthermore, due to faster deterioration of general condition, the tolerance of NSBB in these patients might be remarkable and lead to a higher withdrawal rate. Therefore, it is very important to clarify whether there is additive therapeutic effect of NSBB to endoscopic treatment in the 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

Therefore, the investigators design a study to randomize patients with HCC and acute variceal bleeding to endoscopic treatment alone and combination with endoscopic treatment and NSBB. This is the two years study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HCC, endoscopically proven gastroesophageal variceal bleeding
* Aged 18 to 80

Exclusion Criteria:

* Had a terminal illness of any major organ system,such as heart failure, kidney failure, COPD
Access in Dialysis for Better Outcomes in Patient Therapy

This is a prospective, multi-center health economic study in Canada. Participants will be randomly assigned to receive either the study or control dialysis catheter. The primary objective is to evaluate resource utilization in Ontario related to hemodialysis catheter placement including tissue plasminogen activator (tPA) usage, catheter exchange rates, catheter patency, and missed dialysis days.


Eligibility Criteria:
Inclusion Criteria:

* Is indicated for a dialysis catheter for the purpose of attaining long-term vascular access for hemodialysis. Long-term vascular access is defined by physician anticipated duration of hemodialysis for three months or longer.
* Is ≥ 18 years of age.
* Is indicated to receive dialysis treatment at a location where dialysis treatment data will be accessible by the study team.
* Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study.

Exclusion Criteria:

* Has known or suspected presence of other device-related infection, bacteremia, or septicemia or has been treated with antibiotics for documented or suspected infection within prior 45 days.
* Is receiving prophylactic anti-coagulation or anti-platelet pharmacotherapy for the purpose of central venous catheter (CVC) patency (anti-coagulation or anti-platelet pharmacotherapy for therapeutic indications do not exclude the patient from the study).
* Has severe chronic obstructive lung disease.
* Had past radiation therapy at the prospective insertion site.
* Had previous episodes of venous thrombosis or vascular surgical procedures at the prospective insertion site.
* Has local tissue factors that will prevent proper device stabilization and/or access.
* Has a stent placed in the vessel where the catheter will be placed
* Is pregnant
* History of drug or alcohol abuse in the past 12 months obtained from patient record and/or interview
* Subjects who weigh ≤ 30 kg.
* Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.
Spanish Version of Credibility and Expectancy Questionnaire in Patients with Musculoskeletal Injuries

Physiotherapy treatment of musculoskeletal injuries should be performed following the main clinical guidelines of person-centered care. Patients' perception of the abilities and facilities provided by physiotherapists boost a convenient therapeutic relationship. This relation is linked with more satisfaction and adherence during the treatment, as well as credibility and expectancy of the patient related to the treatment. Thus, Credibility and Expectancy questionnaire is normally used to assess that point. CEQ presents good psychometric properties when used in Physisiotherapy interventions, but there is not a spanish version of this questionaire.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer patients who are going to start physiotherapy treatment due to musculoskeletal injuries.
* Age above 18 years old.
* Understanding of the study purpose and signing the informed consent.

Exclusion Criteria:

* Patients with cognitive deprivation.
* Not able to fill in the questionnaires autonomously.
* Mother tongue different from Spanish.
Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered intravenously allows an area of heart muscle damage after heart attack to be visualised using a magnetic resonance scanner.

Using ferumoxtran (Feraheme) as a USPIO contrast agent for magnetic resonance imaging at 3 Tesla, we aim to conduct the first clinical study to examine the utility of this novel contrast agent to image myocardial inflammation after myocardial infarction.

We will test the following hypotheses in patients who have suffered recent acute myocardial infarction.

1. Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
2. The spatial extent of the MRI signal change evoked by ferumoxytol in the myocardium is proportional to the volume of infarcted myocardium (as assessed by a gadolinium late-enhancement study).
3. Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Presentation with myocardial infarction (either 'ST-elevation' myocardial infarction or 'non-ST-elevation' myocardial infarction
* Troponin I ≥ 10 IU/mL at 12 hours after the onset of chest pain
* Age 18 - 80 years inclusive

Exclusion Criteria:

* Known critical (≥95%) left main stem coronary artery disease
* Continued symptoms of angina at rest or minimal exertion
* Atrial fibrillation
* Symptomatic heart failure; Killip Class ≥2.
* Hepatic failure (Childs-Pugh grade B or C) or renal failure (estimated glomerular filtration rate \<25 mL/min)
* Contraindication to magnetic resonance imaging
* Past history of systemic iron overload/haemochromatosis
* Patients with known allergy to dextran- or iron-containing compounds
Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy

Osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. Despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of sustaining a second osteoporotic fracture, the efforts to prevent these fractures remain inadequate. The in-hospital initiation of antiosteoporotic treatment in patients that have been admitted due to hip fracture has shown to improve treatment rates and contribute to second fracture prevention. For this purpose the Arbeitsgemeinschaft für Osteosynthesefragen (AO) Foundation has introduced an algorithm that can be used by Orthopedic surgeons for the prevention of second fracture in patients that have already suffered an osteoporotic fracture. The purpose of this thesis is to study the efficacy of this algorithm in preventing the second fracture in the greek population. The study will include patients that have been admitted in the Orthopedics department of the University Hospital of Heraklion due to hip fracture. Bone density measurement will be performed using the DXA method and antiosteoporotic treatment will be administered according to the algorithm. These patients will be included in the hip registry of the Orthopedics department and the follow-up will last for 2 years .The primary aims of the study are: a)evaluation of the adherence to the antiosteoporotic medication b)the efficacy of the adherence to the aforementioned clinical algorithm in the secondary fracture prevention in the greek population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hip fractures after low-energy falls(fragility fractures)

Exclusion Criteria:

-Patients with hip fractures after high energy falls
Efficacy of Positive Mental Health Program for Adults - Study Protocol

The aim of this study is to evaluate the efficacy of a positive mental health program for adults, designated Mentis Plus+, in community. Our hypotheses are:

1. compared with the wait-list control group, the persons who join the experimental group and participate in the Mentis Plus+, will have more positive mental health on the end of the program;
2. in the Mentis Plus+ participants, positive mental health will be increased at the end of the program and at follow-up (three- six months later) and their psychological vulnerability will reduce.


Eligibility Criteria:
Inclusion Criteria:

* to be a participant aged ≥ 18;
* participant without a diagnosis of psychiatric pathology;
* agree to participate in the program by signing informed consent;
* participant with the "low-level or languising" in at least one factor of the positive mental health questionnaire

Exclusion Criteria:

* non-Portuguese speakers
Transfusion Reaction by Washed Red Blood Cell (RBC)

The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total hip replacement arthroplasty

Exclusion Criteria:

* Patients who do not agree with this clinical study.
* Patients who have a history of transfusion for recent 1 month.
* Patients who have rare blood types.