cyrilzakka/clinical-trials huggingface dataset:
Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

Patients are admitted to the critical care unit of the hospital because of medical conditions that have a high likelihood of causing severe problems with blood flow, breathing, or brain function. These conditions also have a high likelihood of causing death. Approximately 10 to 15% of all critically ill patients die in hospital. A large amount of scientific evidence suggests that a substantial proportion of these deaths is due to a combination of blot clotting and inflammation in the blood vessels.

Statins are drugs that interfere with cholesterol and fat metabolism. Cholesterol and fat in the blood are associated with blood clotting and inflammation in the blood vessels. Statins are known to be very beneficial in improving the survival after heart attacks, and in preventing heart attacks.

The question that VASTVALUS asks is: do statins improve survival among all critically ill patients? In VASTVALUS, we will concentrate on patients that do not currently require a statin because of their medical condition e.g. after a heart attack, but we are concerned with the rest of the critically ill. In VASTVALUS, participating patients will receive either atorvastatin 80 mg daily or a placebo. Atorvastatin is a statin with a well-established record of safety and effectiveness. A placebo has no known medical activity. We will follow all patients in VASTVALUS to determine whether atorvastatin has any effect on the occurrence of death, stroke, heart attack, or kidney failure among the critically ill. Results from VASTVALUS will be shared with the medical community after the study is completed. As with all clinical trials, patients in VASTVALUS participate of their own choice, and can change their mind at any time.


Eligibility Criteria:
Inclusion Criteria:

* 1. Men or women \>18 years of age
* 2. Admitted to a critical care unit and requiring at least a 48 hour critical care unit stay for medical reasons. Medical reasons include:

  * conditions of cardiovascular,
  * respiratory, or
  * neurologic impairment that require supportive care and observation.

Exclusion Criteria:

* 1. Hepatic failure (Childs-Pugh class C)
* 2. Rhabdomyolysis
* 3. Allergy or hypersensitivity to this drug or any of its components
* 4. Previous intolerance
* 5. Enrolment in another interventional trial
* 6. Contraindication to gastric and/or small bowel drug administration
* 7. MI as major diagnosis at admission (statin indicated)
* 8. Coronary artery intervention within previous 3 days
* 9. Currently receiving a statin or indicated (MI, dyslipidemia)
* 10. Pregnancy
* 11. personal or family history of hereditary muscular disorders
* 12. previous history of muscle toxicity with another HMG-CoA reductase Inhibitor
* 13. concomitant use of a fibrate or niacin
* 14. hypothyroidism
* 15. alcohol abuse
* 16. excessive physical exercise
* 17. renal impairment
* 18. diabetes with hepatic fatty change
* 19. surgery and trauma
* 20. frailty
* 21. situations where an increased plasma level of active ingredient may occur
MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

The purpose of this study is to access the efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis with renal involvement.

The ANCA-associated vasculitides can be life threatening. Glucocorticoids and cyclophosphamide therapy is effective in about 80% patients. However, the side effects such as bone marrow suppression, infection, cystitis, infertility, myelodysplasia preclude further use of cyclophosphamide in some patients and the relapse rate is high.

Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF), could exhibit multifarious effects on endothelial cells, including inhibition of ICAM-1 expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus nephritis with vasculitic lesions. This study was a feasibility study to assess the safety and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared with pulse intravenous cyclophosphamide. After enrollment, subjects were followed longitudinally, and formal measurements of disease activity were determined using the Birmingham Vasculitis Activity Score (BVAS).

Eligibility Criteria:
Inclusion Criteria:

1. A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology.
2. Renal involvement attributable to active ANCA associated vasculitis with at least one of the following:

   * Elevated serum creatinine between 150 and 500 umol/l - renal biopsy
   * Demonstrating paucin -immune necrotizing glomerulonephritis
   * Red cell casts
   * Haematuria with \> 30 red blood cells/HPF and proteinuria \> 1g/24h
3. Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA
4. Age 18\~65 years

Exclusion Criteria:

1. More than two weeks treatment with cyclophosphamide (CYC) or other cytotoxic drug within previous 6 months or with oral corticosteroids (OCS) for more than 4 weeks
2. Co-existence of another multisystem autoimmune disease, e.g. SLE
3. Serum creatinine \> 500umol/l
4. Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
5. Congenial or acquired immunodeficiency
6. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence)
7. Previous malignancy
8. Pregnancy or inadequate contraception if female
9. Anti-GBM antibody positivity
10. Cerebral infarction due to vasculitis
11. Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour
12. Massive gastro-intestinal bleeding
13. Heart failure due to pericarditis or myocarditis
14. Liver dysfunction measured on at least 2 separate occasions
15. Age \< 18y or Age \> 65y
Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)

The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France.

TheraSphere is a radioembolic therapeutic device used in the treatment of liver cancers. The goal of the registry study is to collect prospectively: participant description, treatment goal, treatment description, treatment results, safety, quality of life and survival data to ultimately demonstrate that TheraSphere treatment meets the claims that led to the reimbursement in France. The registry study is also an opportunity to improve the proper use of the device by team training especially for the personalized dosimetry treatment approach.

Clinical data will be collected and held in a secured, validated system and can be downloaded by Biocomplatibles UK Ltd Data Management on an ongoing basis. Data verification will be performed by Biocompatibles UK Ltd Data Management and data validation checks will be created by the validated data system (with the Biocompatibles UK Ltd team performing User Acceptance Testing on them before they go live). Adverse Events and concomitant diseases will be coded according to the version of Medical Dictionary for Regulatory Activities (MedDRA) agreed with Biocompatibles UK Ltd. Concomitant medications will be coded using the version of the World Health Organisation (WHO) Drug dictionary agreed with the validated data system.

Appropriate study plans implemented to manage all aspects of the trial to ensure quality and integrity of the data collection.

Eligibility Criteria:
Inclusion:

* Participant has received a reimbursed dose of TheraSphere®
* Participant does not oppose to the collection of his/her medical personal data

Exclusion:

* Participant has opposed to data collection
* Participant has not received a reimbursed dose of TheraSphere® (free of charge dose)
Psychological Factors in Cardiac Surgery

The study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard information. Hypothesis: Elaborated information about adverse events will increase adverse event occurrence, mediated by expectations and anxiety, and moderated by coping style.

If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 and older) undergoing elective cardiac surgery at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Exclusion Criteria:

* Patients who have previously had cardiac surgery
* Cardiac surgery with deep hypothermia (\<32 degrees Celsius)
* Acute surgery
* Patients with psychiatric or neurological disease who are unable to collaborate with the study protocol
* Patients who do not speak/read Danish
Home Remineralization of White Spot Lesions With Two Different Toothpastes.

The aim of the study is to compare white spot lesions before, during and after treatment with New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite and Colgate toothpaste with 1450 ppm of fluoride. The timeline will consider the study begin, 15 days, 30 days and 90 days after the beginning of the study. The following indices will be recorded: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.

The aim of the study is to compare white spot lesions before, during and after treatment with two different toothpastes for home oral care. Patients who agree to sign the informed consent will be randomly assigned to two different groups:

* Trial Group will use New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite;
* Control Group will use Colgate toothpaste with 1450 ppm of fluoride.

At the baseline, professional oral hygiene will be performed. The following indices will be recorded at the study begin and at the following 15, 30 and 90 days: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* patients with white spot lesions;
* patients with dental sensibility;
* adult patients;
* patients that sign the informed consent to participate to the study.

Exclusion Criteria:

* patients with low compliance or motivation to participate to the study;
* patients not presenting white spot lesions;
* patients with absence of dental sensibility;
* patients pregnant or breastfeeding;
* underage patients;
* patients with psychiatric diseases.
Bacterial Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery

Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections.

The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.

ibid.

Eligibility Criteria:
Inclusion Criteria:

* All children with chronic ear infections scheduled for surgical interventions

Exclusion Criteria:

* Children who have undergone prior mastoid surgery, or children with oncologic treatments.
The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19

This study is aimed to explore the dual-dimensional early intervention strategy of standard of care combined with host immunomodulation in elderly patients with mild and moderate COVID-19.

In this multicentre, randomized, controlled, and adaptive platform trial exploring the efficacy and safety of short-term and low-dose glucocorticoid combined with standard of care in mild or moderate elderly patients (with or without other high-risk factors) who are over 65 years.We are looking for the best treatment strategy to prevent mild or moderate COVID-19 from developing into severe/critical COVID-19, so as to reduce the risk of disease progression and death in the elderly patients and benefit more patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65;
* Male or female;
* Positive test for coronavirus antigen or nucleic acid；
* Within 7 days of onset (fever and/or cough) ；
* mild and moderate；Mild: respiratory tract infection is the main manifestation, such as dry throat, sore throat, cough, fever；Moderate: continuous high fever\>3 days or (and) cough, shortness of breath, etc., but respiratory rate (RR)\<30 times/minute, oxygen saturation\>93% when breathing air at rest. Imaging findings of characteristic pneumonia caused by COVID-19 infection；
* The patient is willing to participate in the trial treatment and follow-up, and sign the informed consent form (if the patient lacks the ability to give informed consent due to his serious medical condition, such as acute respiratory failure or the need for respiratory support, he can obtain the consent of the patient's legal representative)；
* No systemic glucocorticoids treatment in the past 7 days；

Exclusion Criteria:

* Serious and uncontrolled comorbidities；
* Expected lifetime is less than 1 month；
* Severe/critical;
* Other situations that are evaluated by researchers as not suitable for participating the study.

Criteria for discontinuation

* The subject could not benefit after treatment (discontinued patients could be analyzed according to the PP analysis set);

Withdrawal criteria (if any of the following items are required)

* The subject asked to withdraw from the study;
* The subject needs to withdraw from the study after clinical observation after discontinuing treatment;
* The subject died or lost to follow-up.
Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults

The COVID-19 pandemic is causing unprecedented morbidity and mortality.The safe and effective Novel coronavirus vaccine is an effective means to block the transmission of the virus by building up the immune barrier of the population.Clinical studies have shown that elderly people are at high risk of severe COVID-19 infection and have poor clinical prognosis.Considering the current situation of aging population in China, the elderly people should be given priority to vaccinate to obtain protection and reduce the risk of novel coronavirus infection.However, the current data on vaccines are mostly from young and middle-aged healthy people, while there is little research data on COVID-19 vaccination in the elderly.This study mainly studied the safety and effectiveness of COVID-19 vaccine in the elderly population and explored its potential immune mechanism.

This study is a prospective, multicenter, controlled , open-label and phase I clinical trial. Older adults in the study included healthy people between the ages of 60 and 80 group. Those who is in line with the inclusion criteria and who is not in conformity with the exclusion criteria received two doses of COVID-19 vaccine at 0 days (baseline) and 21 days, respectively, and were followed up at 1, 3, 6, 9 and 12 months after completion of vaccination.

Eligibility Criteria:
Inclusion Criteria:

* A COVID-19 vaccine is planned.
* Older adults subjects aged 60-80 years or young adults subjects aged 18-59 years.
* Able and willing to follow the requirements of the clinical trial protocol and complete the study follow-up for 12 months.
* HBsAg, anti-HCV, HIV and TPHA were negative.
* Body temperature ≤37.0℃.

Exclusion Criteria:

* People who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
* Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
* Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
* Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc.
* Patients with congenital or acquired angioedema / neuroedema.
* Patients with lymphoma, leukemia and other systemic malignancies.
* Patients with convulsions, epilepsy, encephalopathy, psychiatric disorders and other progressive neurological disorders, or a family history of them.
* Patients with acute attack of chronic diseases.
* During vaccination, immunomodulators, systemic cytotoxic drugs, immune checkpoint inhibitors (PD-1 / PDL-1 / CTLA-4, etc.) and cell therapy, including NK cells, cytokine induced killer cells, Dendritic cells, CTL and Stem cells infusion are required.
* Other conditions determined by the researcher.
Diaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional Voiding

According to the 2016 International Children's Continence Society standardization of terminology of lower urinary tract function in children, dysfunctional voiding (DV) is a "urodynamic entity characterized by an intermittent and/or fluctuating uroflow rate due to involuntary intermittent contractions of the striated muscle of the external urethral sphincter or pelvic floor during voiding in neurologically normal individuals" . Symptoms vary from mild daytime frequency and urgency to daytime and nighttime wetting, pelvic holding maneuvers, voiding difficulties, urinary tract infections and vesicoureteral reflux (VUR).

There are several ways of treating DV, including urotherapy, pharmacotherapy, surgery in the most severe cases, and even Botulinum toxin type A application in certain children. ''Urotherapy'' stands for non-surgical, non-pharmacologic treatment of lower urinary tract function and can be defined as a bladder re-education or rehabilitation program aiming at correction of filling and voiding difficulties. It involves the change of habits that a child has acquired during the period of toilet training and the development of motor control of the micturition reflex. Urotherapy starts with both parental and child education about the importance of regular hydratation and voiding, constipation treatment and genital hygiene. Together with this standard treatment, the pelvic floor muscle (PFM) retraining is initiated, and it includes pelvic floor exercises and various forms of biofeedback (visual, tactile, auditory, electromyography) with the same aim in mind - to help the child establish pelvic floor awareness and control, and relearn pelvic floor muscle relaxation.

During the past decade, it has been shown that the PFMs are not an isolated unit, but a part of the abdominal capsule, which they form together with the diaphragm, superficial and deep abdominal muscles. As lower abdominal and PFM act synergistically, it is important that both be relaxed during voiding. Diaphragmatic breathing exercises are easy to learn and serve to teach the children abdominal relaxation.


Eligibility Criteria:
Inclusion Criteria:

1. Proven dysfunctional voiding according to the ICCS criteria
2. Signed informed consent by parents motivated to participate in the study
3. Previous treatment by pediatricians in primary care with timed voiding, hydratation and constipation management for three months with no significant success

Exclusion Criteria:

1. Neurological disorders
2. Monosymptomatic nocturnal enuresis
3. Mental retardation
4. Structural abnormalities of the lower urinary tract -
Education and Information for Bariatric Surgery Patients

The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs.

Aim: The study aimed to investigate the effect of pre-admission education given to laparoscopic sleeve gastrectomy patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs.

Materials and Methods: This randomized, controlled, experimental, single-blinded study was conducted with 68 patients who met the inclusion criteria and underwent laparoscopic sleeve gastrectomy in the general surgery clinic of a university hospital between December 2022 and October 2023. The CONSORT checklist was used as a guide. Data were collected using the "Perioperative Form," "Visual Analog Scale, and "State-Trait Anxiety Scale" All patients were operated on by the same physicians and received standard perioperative care. Intervention group patients were informed and educated about the surgical process in the outpatient clinic. Anxiety levels were determined one day before surgery. In the postoperative period, vital signs, anxiety, and pain levels were measured 8 times during 48 hours.

Stage 1: Patients who were planned to undergo sleeve gastrectomy surgery were informed about the perioperative period in an appropriate room when they came to the outpatient clinic 2-4 weeks before surgery and were educated about the exercises to be performed before and after surgery. The content of this education included pain management, breathing exercises (use of trifle, deep breathing, coughing), foot rotation, and leg exercises. In addition, the education book prepared by the researchers was given to the patients to make the education and information permanent until the day of surgery.

Stage 2: When the patient was hospitalized, anxiety level with the Trait Anxiety Scale and pain level with VAS were determined one day before surgery.

Stage 3: Postoperatively, the patient's pain level before analgesics every 4-6 hours for 2 days, the patient's anxiety level with the State Anxiety Scale one day after surgery, the development of complications in the postoperative period, vital signs were evaluated, and the duration of hospitalization was recorded

Eligibility Criteria:
Inclusion Criteria:

* being conscious
* not having a diagnosis of psychiatric disease,
* being 18 years of age or older,
* undergoing their first bariatric surgery,

Exclusion Criteria:

* not being conscious
* Having a diagnosis of psychiatric disease,
* Being 18 years of age or younger,
* Not having bariatric surgery for the first time
* to be reoperated
Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg

Infections with enterobacteria producing carbapenemases at the University Hospitals of Strasbourg - descriptive epidemiology and risk factors for infection in the event of colonization

There is a worrying situation of an increase in the number of patients colonized with carbapenemase-producing Enterobacteriaceae (CPE) at HUS.

7 to 15% of patients colonized with EPC would develop an infection with EPC. The cohorts published mainly concern patients hospitalized in intensive care. The associated mortality reported in the literature is high (\> 25%) and greater than that associated with infection with the same bacterium sensitive to carbapenems.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject hospitalized at HUS between 01/01/2011 and 07/31/2021
* Clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase (EPC)
* Subject not having expressed their opposition to participating in the study

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice