cyrilzakka/clinical-trials huggingface dataset:
Hyperlipidemia Therapy TERCET Zabrze Registry

A study conducted to evaluate the efficacy of lipid-lowering therapy in patients with high and very high risk treated by interventional cardiology. Study endpoints:

1. Achievement of the target LDL-C at 1-year follow-up LDL-C \<70 mg / dl in the group of very high-risk and LDL-C \<100 mg / dL in high-risk patients
2. Assessment of the lipid profile of the severity of coronary artery disease in patients undergoing invasive diagnosis of coronary artery disease
3. Evaluation of trends in the treatment of lipid-lowering in patients in different years

The TERCET Zabrze Registry is an observational study of all patients hospitalized due to the cardiovascular diseases. The date include information on the hyperlipidaemia treatment, clinical characteristics, any treatment modalities and prognosis in this population. Data collection is patient-based (not event-based).

The study population is formed by all-comer patients hospitalized in cardiology wards and intensive cardiac care units with a diagnosis of coronary disease, both stable angina, and acute coronary syndromes (ACS). For the purpose of this study hyperlipidaemia is defined in accordance with European Society of Cardiology guidelines.

Complete patient demographics; medical history, complete hospitalization data (diagnostic and therapeutic), in-hospital and out-hospital results are collected in an electronic form by the attending physician. The patients are under constant follow-up for all cause mortality and major adverse events.

Eligibility Criteria:
Inclusion Criteria:

* All patients with coronary artery disease with hyperlipidemia

Exclusion Criteria:

* No coronary artery disease
Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19

The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.

As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age
* Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
* Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
* Severe COVID-19 is defined by one or more of the following:

  1. Dyspnea
  2. Respiratory frequency ≥ 30/min
  3. Blood oxygen saturation ≤ 93%
  4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
  5. Lung infiltrates \> 50% within 24-48 hours
* Life-threatening COVID-19 is defined as one or more of the following:

  1. Respiratory failure
  2. Septic shock
  3. Multiple organ dysfunction or failure

Exclusion Criteria:

* History of prior life-threatening reactions to transfusion of blood products
* Not receiving other therapies that would preclude plasma transfusion
Study of Dry Beriberi in Mayotte, Comoro Archipelago

The purpose of this study is to assess the existence of a genetic factor, suspected to be involved, aside from likely food deficiency contribution, in occurrence of dry beriberi, in patients who experienced dry beriberi and in a case group composed of 3 people, free from beriberi, within the same household.

A team of 2 investigators, a nurse and an investigator speaking French, Shibushi and Shimaore (3 languages in use in Mayotte), will visit exposed patients who agreed to participate to the study.

3 controls, fulfilling inclusion criteria, will be recruited within the household by drawing lots.

Clinical examination and food survey by means of a questionnaire will be performed.

Blood samples will be drawn to determine thiamine status, vitamin B1 dosage, erythrocyte transketolase activity and thiamine pyrophosphate effect, analysis will be performed by Biomnis laboratory in Lyon.

For the genetic study, 4 drops of blood will be put down on Whatman paper and sent to Dr Johannes COY in Darmstadt Germany, for DNA extraction and PCR screening for mutations.

Eligibility Criteria:
Inclusion Criteria:

* patients
* Native to the Comoro Archipelago (Grande Comore, Mayotte, Anjouan, Mohéli)
* Fulfilling the clinical definition of the dry beriberi.
* Both sexes.
* Older than 15 years and 3 months (limit of the paediatrics).
* Having signed and whose legal representatives signed the form of assent, having understood the information.
* Benefiting from a social coverage regime.
* Controls
* Native to the Comoro Archipelago.
* People living in the same household as the patient, sharing the same meals.
* Both sexes.
* Older than 15 years old and 3 months.
* Free from beriberi.
* With normal neurological examination.
* Having signed and whose legal representatives signed the form of assent, having understood the information.
* Benefiting from a social coverage regime.

Exclusion Criteria:

* Aged under 15-year-old and 3 months.
* For the patients and the witnesses, the presence of pathologies known to increase needs in vitamin B1 (cancer, infectious diseases, fever, hyperthyroïdism, chronic alcoholism).
Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty

A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.

Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.

In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Unilateral knee replacement
* Must be able to give oral and written consent

Exclusion Criteria:

* General Anesthetized
* Allergic to Tranexamic acid
* In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
* Use of oral anticonceptive.
* Reduced kidney function (S-creatinine \> 120 micromol/L)
* Medicine or alcohol abuse
* Females with menstruation within the last 12 mounts.
* Any kind of cancer disease
* Rheumatoid arthritis
* Have participated in a clinical trial within the last 30 days.
Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients

Vitamin D is a secosteroid hormone which may have beneficial role in reducing COVID-19 adverse outcomes by first regulating the renin angiotensin system (RAS). Recent studies on animal in which acute respiratory distress syndrome (ARDS) was induced, showed that vitamin D lead to pulmonary permeability reduction by modulating RAS activity as well as the expression of the angiotensin-2 converting enzyme (ACE2). During COVID-19, downregulation of ACE2 leads to cytokine storm in the host, causing ARDS. In contrast, an experimental study conducted on mice in which ARDS was induced chemically, revealed that vitamin D admiration contributed to mRNA and ACE2 proteins levels improvement, ADRS milder symptoms as well as less lung damage.

Additionally, vitamin D had shown antiviral effects on several previous studies, that though to be exerted either by antimicrobial peptides induction which subsequently had direct antiviral action or through immunomodulatory and anti-inflammatory effects.

In addition, vitamin D stabilizes physical barriers which prevent viruses from reaching tissues susceptible to infection. Finally, previous studies demonstrated that hypovitaminosis D is accompanied by various comorbidities including diabetes mellitus, hypertension, chronic cardiovascular and respiratory diseases, and cancers, all medical conditions that are considered risk factors of COVID-19 infection deterioration and even high mortality rate.

The objective of this study is to evaluate whether supplementation with high-dose vitamin D improves the prognosis of patients diagnosed with COVID-19 compared to a standard dose of vitamin D.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65 years.
2. COVID-19 hospitalized patients with pneumonia confirmed by chest X-ray or CT scan.
3. RT-PCR Confirmed infection with COVID-19 or strongly suspected infection with pending confirmation studies.
4. Presence of acute respiratory distress syndrome (ARDS).
5. Having either peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg.

Exclusion Criteria:

1. Vitamin D supplementation in the previous month.
2. Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D.
3. Organ failure requiring admission to a resuscitation or high dependency unit.
4. Pregnant women.
5. Participation in another simultaneous clinical trial.
Can Resistance Enhance Selection of Treatment? (CREST)

To compare two commercially available platforms for assessment of HIV drug resistance to determine which provides superior virological results.

We hypothesise that one test will be significantly superior to the other.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA\> 2000copies/mL, who were willing to change ARVs and who provided informed consent.

Exclusion Criteria:

* Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.
A Stepped Wedge Cluster Randomized Controlled Trial to Assess a Strategy Aiming to Optimize Psychosocial Outcomes in Patients With Cancer

INTRODUCTION Our group previously demonstrated the feasibility of the Hucare Quality Improvement Strategy - HQIS, aimed at integrating into practice 6 psychosocial interventions recommended by international guidelines. This randomized trial is designed to assess whether the introduction of the strategy in oncology wards improves patient quality of life.

METHODS AND ANALYSIS This is a multicenter, incomplete stepped-wedge cluster randomized controlled trial, where the intervention strategy is sequentially carried out in three groups of centers (clusters with 5 centers each) and in three equally spaced time periods (epochs) (every 4 months). The study also includes an initial epoch during which none of the centers is exposed to the intervention, and a final epoch when all centers will have implemented the strategy . The intervention is applied at a cluster level (unit of randomization) and assessed at an individual level with cross-sectional model. 720 patients will be included, i.e. 60 patients in each cluster for every detection epoch.

Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of improvement of at least one of two domains of HRQoL using the EORTC QLQ-C30 questionnaire, detected at baseline and 3 months after enrolment.

The HQIS comprises three phases: 1) clinician training - to improve communication-relational skills and to instruct on the project; 2) center support - 4 on site visits by experts of the project team, aimed to introduce the project and boost motivation, instruct staff on how to implement recommendations, help with context analysis and identification of solutions; assess actual implementation in the center; 3) implementation of EBM recommendations.

ETHICS AND DISSEMINATION Ethics committee review approval has been obtained from the Ethics Committee of Parma. Results will be disseminated at conferences, in peer-reviewed and professional journals intended for policymakers and managers.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Diagnosis (histological or cytological) of solid tumor communicated to the patient within the previous two months
* About to start a new medical cancer treatment: chemotherapy (IV or oral), molecular target drugs, hormonal therapy, immunotherapy
* Expected survival \> 3 months
* Good comprehension of the Italian language
* Who have read, understood, and signed the informed consent.

Exclusion Criteria:

* Previous chemotherapy or other medical cancer treatment
* Recruited in a previous epoch of the study (that is, patients can only participate during one epoch)
* Currently participating in other trials which imply the completion of Patient Reported Outcomes (PROs) in the same period
* Hospitalized
* Currently receiving psychiatric treatment
* Affected by mental or psychiatric disorders, due to cancer or coexisting illness, which interfere with the state of consciousness or impede judgment
* Inability to complete the questionnaire or ensure participation in the three-month follow-up
Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study

Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor prognosis as there are no recommended curative treatments. Chemoembolisation is the most widely used treatment in these patients, but this technique can prove to be toxic. intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective therapeutic approach, without deteriorating liver function.

The rationale for this treatment can be resumed as follows:

* HCC are vascularised via the hepatic artery system
* The IHA perfusion of anthracyclines leads to high elimination via the liver with low systemic concentrations
* The absence of embolisation reduces toxicity
* the toxiciity profile of idarubicin is well known and the drug is widely used for the IV treatment of leukemia
* idarubicin is the most cytotoxic drug for tumor cell lines.
* The in vitro cytotoxicity of idarubicin is 100% at low concentrations
* Lipiodol can stay in contact with tumor tissue for several weeks after injection and act as a vector for the drug
* The idarubicin-lipiodol is more stable than lipidol emulsions usually given by intraarterial injection
* The emulsion is more stable with idarubicin than with other anticancer molecules
* Sequential inclusion in accordance with the "continual reassessment method" makes it possible to increase inclusions at a target toxicity level while reducing inclusions at doses that are too low or too toxic The aim of the treatment is to improve survival.


Eligibility Criteria:
Inclusion criteria:

Histologically-proven hepatocellular carcinoma or carcinoma meeting validated non-invasive criteria (EASL, AASLD)

* Child-Pugh A OR B7 cirrhosis
* General health status WHO 0.1
* Platelets \> 50 000/mm3, Polynuclear neutrophils \> 1000/mm3
* Creatininemia \< 1.5 times upper limit of normal
* LVEF by MUGA scan or US \> 50 %
* Age \> 18 years
* Signed informed consent
* For women child-bearing age, an effective means of contraception

Exclusion criteria:

Patients who can benefit from curative treatment (surgical resection, liver transplant or treatment via percutaneous destruction)

* Non-cirrhotic liver
* Cirrhosis Child B8 or B9 or C
* Extrahepatic metastases (pulmonary micronodules \< 7mm are not considered a contra-indication)
* Digestive hemorrhage within the previous month
* Patient on anticoagulants
* Pregnant women
* Uncontrolled infection
* Hypersensitivity to anthracyclines
* Hypersensitivity to iodine contrast agents
* Patient under guardianship or ward of court
* Patients who have already received the recommended cumulative dose of anthracycline (93 mg/m2 for idarubicin, 140 mg/m2 for mitoxantrone, 550 mg/m2 for doxorubicin, 600 mg/m2 for daunorubicin, 900 mg/m2 for epirubicin)
Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy

Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

The purpose of the research is to Describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

In a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110), UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8, D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft, Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate, preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar,

Exclusion Criteria:

* Patients with pathologies that may seriously affect VA postoperatively
Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy

Acute liver failure in cirrhotic patients is associated with a one-month mortality of 48%. Encephalopathy, largely related to hyperammonemia, is a frequent complication of liver failure and is a poor prognostic marker. Lactulose decreases ammonia by acidification of the colon, replacement of urease-producing bacteria and creation of a laxative effect. Thus, the administration of lactulose in patients with severe hepatic encephalopathy reduces mortality by more than 40%.

In intensive care patients, lactulose is often administered rectally. The use of simple rectal tubes is associated with frequent leakage of lactulose as well as faecal discharge and therefore risks of infection and skin lesions. Balloon rectal tubes with a drug delivery valve have recently been developed and used in this indication. The aim of this study is therefore to describe the use of these balloon rectal tubes to administer Lactulose in severe hepatic encephalopathy.

This suggests that ammonia reduction in these patients may prolong survival time.

No studies have described the administration of Lactulose via the rectal route with a balloon tube. The descriptive methodology is therefore appropriate. This is a preliminary study allowing data collection to establish the methodology for a subsequent clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Patients treated with Lactulose with balloon rectal probe

Exclusion Criteria:

* Patient(s) objecting to the use of their data for research purposes
* Rectal probe contraindication: damage to the rectal mucosa, rectal surgery, severe haemorrhoids, rectal stenosis, rectal tumour,
* Lactulose contraindication (person unable to absorb galactose)
* Patients deprived of liberty, under guardianship or curators
* Pregnant women
* Patient not affiliated to a social security scheme
Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.

The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.

Cardiac surgery performed through median sternotomy is associated with significant postoperative pain.Poststernotomy pain leads to decreased patient satisfaction, delirium, cardiovascular complications (hypertension, tachycardia, arrhythmias), hyperglycemia and respiratory complications (bronchial secretion stasis, atelectasis and pneumonia).High-dose opioids can provide good postoperative analgesia for patients undergoing heart surgery. However, opioids have some side effects.The advent of ultrasound-guided regional anaesthesia led to the development of fascial plane chest wall block as transthoracic plane block and pectointercostal fascial block.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years.
2. Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
3. American Society of Anesthesiologists classification of physical status \< IV.

Exclusion Criteria:

1. Emergency surgery.
2. Off-pump surgery.
3. Redo surgery.
4. Ejection fraction less than 35%.
5. Refusal of the patient.
6. Known hypersensitivity to LA.
7. Chronic opioid use or chronic pain patient.
8. Psychiatric problems or communication difficulties.
9. Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7)
10. Renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min).
11. Obstructive sleep apnea syndrome.
12. Coexisting hematologic disorders.
13. Pregnancy or breastfeeding.
A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

This study is a randomized, double-blind, placebo-controlled, dose-ranging, parallel, multi-center, phase II study to evaluate the efficacy and safety of MT921 in subjects with moderate to severe submental fat.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 19 and under 65 years old
* Subjects achieving CA-SMFRS and PA-SMFRS score of 2 or 3
* Subjects who voluntarily signed the Informed Consent

Exclusion Criteria:

* Subjects who had liposuction or other procedures on the treatment area that might affect the assessment.
* Subjects with BMI over 35.0kg/m\^2
* Subjects with dysphagia
* Subjects who are allergic or hypersensitive to the investigational product
* Subjects who are pregnant or lactating, or does not agree to use an accepatble form of contraception during the clinical trial.
* Subjects who are otherwise deemed uneligible by the investigator.