cyrilzakka/clinical-trials huggingface dataset:
Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research

The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. Possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies


Eligibility Criteria:
Inclusion Criteria:

* Signed inform consent
* Histolgically verified solid tumour
* Receiving systemic therapy for neoplasm
* Has archival tumour tissue
* Provide biosamples with living tumour tissue or blood samples for immunologic assessment

Exclusion Criteria:

* Concurrent Lymphoprolipherative disorder
* Patients after stem cell or bone marrow thansplantation
* Incomplete informaton on previous cancer history or medical history
* Patients with known primary immunodeficiency
* Patients receiving immunosupressive therapy for concurrent illness
* Pregnant patients
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy

The objective of this clinical study is to Evaluate the Efficacy and Safety of BR1019A and BR1019B combination therapy in Patients with Essential Hypertension and Type 2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Those with type 2 diabetes mellitus \& essential hypertension
* Those who agree to discontinue existing antihypertensive and/or oral hypoglycemic drugs during the clinical trial
* Those who are judged medically reasonable by investigator to be able to discontinue existing antihypertensive and/or oral hypoglycemic drugs(except for Metformin) during the clinical trial

Exclusion Criteria:

* Those who meet the following criteria

  * Those with a history of secondary hypertension or suspected secondary hypertension; (Including but not limited to; e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
  * Those with clinical significant orthostatic hypotension accompanied by symptoms
  * Those with diabetes mellitus taking renin inhibitors(Aliskiren) or moderate to severe renal impairment
  * Those with diabetic nephropathy taking ACE inhibitors
  * Those with type 1 diabetes mellitus, secondary diabetes mellitus, severe insulin-dependent diabetes, diabetic ketoacidosis or lactic acidosis
  * Those with uncontrolled, severe diabetic complications (Micro-vascular complications(e.g., nephropathy, retinopathy, neuropathy, etc.), Macro-vascular complications)
  * Diabetic coma or pre-coma
Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome

In assisted reproductive technology, adenomyosis patients are characterized by lower clinical pregnancy rate, lower implantation rate and higher abortion rate. The purpose of this study is to explore whether low molecular weight heparin can reduce the abortion rate of adenomyosis patients in frozen thawed embryo transfer cycles.


Eligibility Criteria:
Inclusion Criteria:

1. The basal serum level of FSH was less than 10 IU / L
2. Diagnosed with adenomyosis by ultrasound
3. The first frozen thawed embryo transfer cycle, by hormone replacement protocol
4. Transfer at least one high quality frozen embryo;
5. Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person.

Exclusion Criteria:

1. With abnormal karyotype;
2. Accompanied with other uterine diseases: intrauterine adhesion, intramural myoma, moderate to severe endometriosis, congenital uterine malformation, endometrial tuberculosis, thin endometrium \< 8mm on the day of transformation, etc;
3. PCOS, RIF patients;
4. There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc;
5. There were contraindications to hormone replacement therapy and low molecular weight heparin;
6. Participating in other clinical studies;
7. Unable to follow-up
Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning.

It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are no large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.

The investigators have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. The investigators will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product.

The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenic subjects (according to DSM-IV-TR criteria) from throughout Sicily, (Italy), who smoke tobacco cigarettes, in stable phase of illness.
* smoke ≥10 factory made cig/day, for at least the past five years
* age 18-65 years
* in good general health
* not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months
* committed to follow the trial procedures.

Exclusion Criteria:

* use of smokeless tobacco or nicotine replacement therapy
* pregnancy or breastfeeding.
* current or recent (less than 1 yr) past history of alcohol and/or drug abuse
* other significant co-morbidities according to the Investigator's clinical assessment
Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients

The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will be utilized during the surgical procedure to evaluate its potential as a possible predictive device for delirium.

This is a single center prospective randomized double blinded placebo controlled study.

The primary aim of the study is to optimize the intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction. Secondary aims are to determine the dose response relationship for intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will reduce post-operative pain and opioid requirements, determine if raw electroencephalogram (EEG) data can predict postoperative delirium during general anesthesia, and to evaluate length of intensive care unit (ICU) and length of hospital stay.

Participants will be randomized to one of three groups after administration of general anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV placebo.

An EEG will be used during the surgical procedure to gather raw data for off line analysis among patients developing post-operative delirium.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia
* Competent to provide informed consent

Exclusion Criteria:

* Emergency surgery
* Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general anesthesia)
* Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement
* Poor health literacy
* Allergy, or have experienced any drug reaction to ketamine
* Pregnant or lactating
* Currently in active alcohol withdrawal
* Taking buprenorphine for chronic pain
Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.

Facet joint pain is considered as a nonspecific cause of spinal pain with an estimated prevalence of 12-61% of the population. At present, there are no unanimous clinical criteria to achieve and accurate diagnosis and the imaging findings do not show a direct correlation with the clinical symptoms.

Facet syndrome treatment is also controversial and, although most clinical guidelines recommend nerve block as a diagnostic test, followed by neurolysis as therapeutic technique, there are many detractors of this therapeutic sequence.

The confusion is even greater when considering the variability of specialists who perform these techniques, the variability of methods used ranging from blind injections to injections guided by ultrasound, fluoroscopy or CT, or the amount of medication injected.

The investigators have long experience in the percutaneous treatment of pain and in the use of different imaging techniques. Although the investigators objectives are multiple, the main one is to know if there are any difference in the outcome of the facet syndrome treated by intra-articular injections and the block of the medial branch of the dorsal branch of the spinal nerve.

Along with the collaboration of other specialists the investigators want to address secondary objectives such as the usefulness of ultrasound and fluoroscopy in the treatment of facet syndrome and its comparison with those performed under CT guidance that is considered as the standard technique for its greater precision.

Eligibility Criteria:
Inclusion Criteria:

1- Lumbar facet syndrome diagnosed by the referring specialist: Rehabilitation, Traumatology or Neurosurgery 2 -Mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation.

3- failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months

Exclusion Criteria:

1. Previous back surgery and other ablative treatments.
2. Contraindication for the use of corticosteroid or local anesthetic.
3. Uncontrolled acute or chronic medical illness.
4. Pregnancy or lactation.
5. Presence of inflammatory arthropathy or neuropathy.
6. Wounds or skin lesions in the area.
7. Diabetes mellitus.
8. Psychiatric disorders
9. Refusal to participate in the study.
10. Demonstration by imaging techniques of other causes that could justify the symptomatology.
a Novel Individualized Substrate Modification Approach for the Treatment of Long-standing Persistent Atrial Fibrillation

The purpose of this study is to compare effectiveness of two substrate modification approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a substrate-based, individualized substrate modification (ISM)approach should be superior to traditional stepwise ablation(SA). To the best of investigator's knowledge, this was the first study to evaluate the "real" substrate by means of electro-anatomic mapping and to perform "true" substrate modification in long standing persistent atrial fibrillation ablation(LPAF).

Catheter ablation (CA) is highly effective for paroxysmal atrial fibrillation(AF), it is modestly effective for long standing persistent atrial fibrillation ablation(LPAF) even with complex or combined approaches, which is mainly attributed to the substrate underlying AF remodeling. Severity of atrial fibrosis is closely associated with clinical outcomes after CA for AF . The more atrial scars and fibrosis present, the lower the success rate for AF ablation. Patients with LPAF have many more areas with scars and fibrosis than those with paroxysmal AF or non-AF controls. The MRI delayed enhancement technique provides a non-interventional tool for evaluation of atrial fibrosis, however, it must be performed in sinus rhythm.Three-dimensional electro anatomic mapping has proven as accurate as MRI and can be performed easily during AF ablation, thus providing a good tool for evaluation of atrial substrate during LPAF ablation.

Although electro-anatomic mapping provided a desirable surrogate for delayed enhancement MRI to define AF substrate, there was an important technical issue to be considered. There were no good techniques to predict a desirable tip-tissue contact before the contact force catheter was applied. A poor tip-tissue contact could render the results of voltage mapping less reliable. On the other hand, excessively high contact force could increase the risk of steam pop and cardiac perforation during ablation. Hence it was important to use the contact force catheter to perform substrate mapping and ablation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 72years
* History of LPAF for ≥1 and ≤ 5 years
* Written informed consent provided
* Acceptance of catheter ablation treatment
* Acceptance of post-ablation follow-up

Exclusion Criteria:

* Prior history of catheter ablation or surgical ablation
* Abnormal coagulation; contraindication for anti-coagulation
* left atrium diameter ≥ 55mm
* left atrium thrombus
EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
2. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
3. Prior use of loop diuretics within 30 says prior to admission.
4. ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter.
2. Hemodynamic instability.
3. Dyspnea due primarily to non-cardiac causes.
4. Acute infection with evidence of systemic involvement.
5. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
7. Inability to follow instructions or comply with follow-up procedures.
8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
9. Severe electrolyte abnormalities.
10. Presence of active coronavirus disease 2019 (COVID-19) infection.
11. Enrollment in another interventional trial during the index hospitalization.
12. Inability to return for follow-up study visits.
13. Life expectancy less than 3 months.
14. Women who are pregnant or intend to become pregnant.
Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients

The goal of this observational study is to compare in anti-HBc (+) grafts/ anti-HBc (-) grafts. The main question it aims to answer is the long-term efficacy of active vaccination and graft/patient outcomes of anti-HBc (+) grafts have yet to be comprehensively investigated. Researchers will compare anti-HBc (+) grafts/ anti-HBc (-) to see if it would affect the long-term survival.

A particular strength of the present study is in the inclusion of a consecutive cohort of pediatric LDLT recipients with long-term details of follow-up, although there are several limitations. First, this was a retrospective study conducted at a single medical center. Second, the HBV prophylaxis changed from lamivudine to entecavir in 2008, therefore investigators were unable to evaluate the risk of developing lamivudine resistance. In addition, the DNA level data for the donor and graft tissues were lacking. Lastly, this study was conducted in an area with a high prevalence of anti-HBc positivity.

Eligibility Criteria:
Inclusion Criteria:

- consecutive pediatric LDLT recipients.

Exclusion Criteria:

* Adult LDLT recipients
Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health

This early-stage study is designed to determine the efficacy of the CE-approved, antibacterial, dual-light Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Dental plaque triggers changes in gingival health, which results in slight swelling and bleeding from the gingival margin and causes gingivitis. Supragingival dental biofilm control can be achieved by mechanical and chemical means. Toothbrushing is effective in reducing levels of dental plaque (van der Weijden \& Slot 2015). It removes plaque from flat, accessible surfaces but is less effective at the gingival margins and in approximal areas, where the accumulation of residual plaque encourages gingivitis and deterioration of periodontal health. Effective toothbrushing is also depending on a number of factors, e.g., age, knowledge, manual dexterity and motivation. Oral hygiene instructions and patient motivation in oral hygiene practices should be an integral part of the patient management during all stages of periodontal treatment (Tonetti et al., 2015). Oral health practice of individuals affects their gingival and periodontal health.

The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Forty (40) patients are randomized to the Lumoral treatment group or the control group. Both groups shall receive standard oral hygiene instructions for sonic toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontal status including visible plaque index (VPI), bleeding on probing (BOP) and probing pocket depth (PPD). In addition, aMMP-8 mouth rinse test and microbiological analysis of gingival pockets will be performed. Digital photographs after staining will be taken. These analyses shall be performed at baseline and at 4 weeks after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Agreement to participate in the study and to sign a written consent form

Exclusion Criteria:

* Presence of any physical limitation or restriction that might restrict Lumoral use
* Pregnancy or lactation
Developing Derived Induced Pluripotent Stem Cells as a Model to Understand Imprinted Disorders

Fetal and postnatal growth is finely regulated by genetic, epigenetic and environmental mechanisms. Parental imprinting is a regulatory mechanism that allows monoallelic expression of certain genes from a single parental allele through differential DNA methylation. Imprinted genes play a very important role in the control of fetal and postnatal growth. The pathophysiological mechanisms of these epimutations are largely unknown.

Studying the consequences of these epimutations on the molecular signature of the imprinted gene network in these patients would provide a better understanding of the epigenetic mechanisms regulating fetal growth. As these genes are weakly expressed in fibroblasts, these studies will be carried out on pluripotent stem cells or IPSCs (Induced Pluripotent Stem Cells).


Eligibility Criteria:
Inclusion Criteria:

1. Minor or young adult patients treated in the department, suffering from rare growth diseases: Silver-Russell syndrome (SRS), Beckwith-Wiedemann syndrome (BWS) and Temple syndrome (TS)
2. For minors, the patient's weight must be ≥ 5 kg

Exclusion Criteria:

* Patients unable to express their opposition to the use of their personal data.
Simplification From Protease Inhibitors to Raltegravir

A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).


Eligibility Criteria:
Inclusion Criteria:

* HIV1 sero-positive using standard diagnostic criteria
* Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization
* On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry

Exclusion Criteria:

* Pregnancy or breast feeding
* Prior use of Integrase inhibitors
* Alcohol or substance abuse if according to the investigator opinion would interfere with compliance
* UIse of investigational medications within 30 days before study entry or during the trial