cyrilzakka/clinical-trials huggingface dataset:
VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT

Although monitoring fluid balance for continuous renal replacement therapy-treated patients is an important issue, most physicians usually use conventional methods such as the difference between the amount of intake and output (I \& O), which is not objective way. Meanwhile, bioimpedance electrical vector analysis presents the patients' fluid status with more objective data. Thus, the investigators will investigate the clinical benefit for monitoring fluid balance when the investigators use InBody S10, one of representative bioimpedance electrical vector analysis, compared with conventional methods among the patients who need continuous renal replacement therapy.

Although monitoring fluid balance for continuous renal replacement therapy-treated patients is an important issue, most physicians usually use conventional methods such as the difference between the amount of intake and output (I \& O), which is not objective way.

Meanwhile, bioimpedance electrical vector analysis presents the patients' fluid status with more objective data.

Thus, the investigators will investigate the clinical benefit for monitoring fluid balance by using InBody S10 (0, 1, 2-day, and 7-day from CRRT initiation), one of representative bioimpedance electrical vector analysis, compared with conventional methods among the patients who need continuous renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for INCLUSION in the study if ALL the following criteria are met;

  1. The treating clinician believes that the patient requires continuous renal replacement therapy for acute renal failure.
  2. The treating clinicians anticipate treating the patient with continuous renal replacement therapy for at least 72 hours.
  3. Informed consent has been obtained.
  4. The patient fulfills ONE of the following clinical criteria for initiating continuous renal replacement therapy:

     urine output \< 100 ml/6 hr that has been unresponsive to fluid resuscitation measures
     * K+\> 6.5 mmol/L
     * pH \< 7.2
     * Urea \> 25 mmol/L
     * Clinically significant organ edema in the setting of acute kidney injury
  5. Patients who are over 5% of fluid overload or their total body water/height\^2 ≥13 L/m\^2

     Exclusion Criteria:
* Patients will be EXCLUDED from the study if, in the opinion or knowledge of the responsible clinician ANY of the following criteria are present:

  1. Patient age is \< 18 years
  2. Death is imminent (\<24 hours)
  3. There is a strong likelihood that the study treatment will not be continued in accordance with the study protocol.
  4. The patient has been treated with continuous renal replacement therapy or other dialysis previously during the same hospital admission.
  5. The patient has been on maintenance dialysis prior to the current hospitalization.
  6. Any other major illness that, in the investigator's judgement, will substantially increase the risk associated with the subject's participation in this study.
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements.

Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. Therefore, we aim to investigate this association through an interventional study design.

Participants will be asked to follow a restricted diet with a low "PRAL" during a 6-week trial divided into three periods: two-week of free-living control, two-weeks of intervention, and a two-week free-living follow-up.

The PRAL calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient. The diet will comply with Danish national guidelines on threshold for potassium and protein, due to the high risk of hyperkalemia in CKD patients. The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24-hour period.

Eligibility Criteria:
Inclusion Criteria:

* Chronic acidosis (plasma-bicarbonate under 22 mmol/l at multiple measures within the last 12 months).
* Diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (eGFR below 30 ml/min/1,73 m2)
* Of legal age and over 18 of years
* Understand danish and understand the written material
* Able to cooperate about the diet
* Able to take pictures with their phone or willing to learn

Exclusion Criteria:

* Vegan and vegetarian with very low intake of animal protein (below 25 g/day)
* Pregnant or breast feeding
* Patients with short bowel syndrome, bricker bladder, pancreatitis or any other known malabsorption problem
* Potassium above 5 mmol/l
* Ongoing infection
Non-Interventional Study With Aricept® Evess

The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week length of the study aims to collect data from a large number of patients (n= 400) on the safety and efficacy at the usual dosage of the product providing an overview of Aricept® Evess profile.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients (male / female), older than 50 years.
* Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.
* MMSE score between 12 - 24.

Exclusion Criteria:

* Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives or any of the excipients of Aricept® Evess.
* Patients with severe impaired hepatic function.
* Patients with pre-existing gastrointestinal ulcer disease.
* Patients with the history of bronchial asthma or chronic obstructive lung disease.
* Patients with the history of serious atrioventricular conduction disturbances.
Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes

This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (OD) or twice daily (BID), with or without oral antidiabetic drugs) (OADs) (metformin, sulphonylurea (SU), glinides, alpha-glucosidase inhibitor, DPP-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before Visit 1
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2

Exclusion Criteria:

* Treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
* Treatment with rosiglitazone or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
* Cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients

This is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients.


Eligibility Criteria:
Inclusion Criteria:

* PDR patients undergoing vitrectomy

Exclusion Criteria:

* patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy
* patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy
* patients who had received complete PRP before vitrectomy
* patients who are pregnant
Screening COVID-19 by Point-of-care Lung Ultrasound: a Validation Study

COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Lung ultrasound (LUS) has similar diagnostic properties as CT for diagnosing pneumonia. However, it has the advantage that it can be performed at point-of-care, minimizing the need to transfer the patient, reducing the number of health care personnel and equipment that come in contact with the patient and thus potentially decrease the risk of spreading the infection.

This study has the objective to examine the accuracy of lung ultrasound in patients with proven COVID-19 pneumonia.


Eligibility Criteria:
Inclusion Criteria:

1. high probability CT thorax or chest X-ray for viral pneumonia within five days of the day of inclusion
2. positive COVID-19 nasopharyngeal swab within 10 days of inclusion
3. 18 years or older
4. Oxygen saturation of \< 93% in ambient air
5. Signed written informed consent

Exclusion Criteria:

* Contra-indication for lung ultrasound
* Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray
Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications

The study is aimed at assessing the role of the activity of high-risk markers of thrombotic events (MCP-1, MIP1α, IP-10, phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.

The study is aimed at assessing the role of the activity of high-risk markers for thrombotic events (monocytic chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP1α), interferon-induced gamma protein-10 (IP-10), platelet apoptosis markers (phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.

The study will include 150 patients of similar age, gender, and ethnicity, and they will be divided into three groups: Group I: 50 patients with confirmed coronavirus infection without thrombotic complications; Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography without the use of pharmacomechanical prophylaxis of VTE; Group III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE

Eligibility Criteria:
Inclusion Criteria:

* men or women over 18 years of age with a new coronavirus infection, confirmed by polymerase chain reaction (PCR) studies and chest CT.

Exclusion Criteria:

* men or women under 18 years of age; active cancer or a remission period of less than 5 years; decompensated somatic pathology; pregnancy or breastfeeding in women.
MRI in Portal Hypertension

Death from chronic liver disease has doubled in the UK over the last decade. This is largely due to the rise in liver disease from excess alcohol consumption, obesity related fatty liver disease and hepatitis B \& C infections. The current 'liver tests' only identify liver injury when the damage is at an advanced stage. They neither estimate the degree of injury accurately nor help judge prognosis. The complications from chronic liver disease result mainly from raised pressures within the liver. We currently measure this pressure by passing a long catheter through the jugular vein in the neck into the liver. This invasive test does carry a small yet significant risk of complications and is not available outside specialised liver centres. Raised pressure within the liver is also associated with changes in the microorganisms within the gut. This leads to increased infective complications among patients with liver cirrhosis.

We aim to noninvasively measure the pressures within the liver using Magnetic Resonance Imaging (MRI). We will recruit 49 patients with chronic liver disease who have had liver pressure measurements as part of their routine clinical assessment. The participants will attend the Biomedical Research Unit and the MR Centre for a single 2hour visit. We will also collect blood, urine and stool samples from them.

The diagnostic accuracy of the quantitative MRI techniques will be validated against the pressures obtained via the invasive test. The quantitative MRI techniques will also correlated with biomarkers of liver injury obtained from blood and urine samples. The stool sample obtained will be used to characterise the gut microorganisms in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of more than 18 years of age.
2. Patients who have had HVPG measurements within the last 6 weeks.
3. Underlying portal hypertension due to chronic liver disease - alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD), chronic hepatitis B or C and heamochromatosis.
4. Patients investigated with a clinical suspicion of portal hypertension, but have normal portal pressures on HVPG measurements.
5. Ability to consent to participate in the study.

Exclusion Criteria:

1. Patients with underlying diseases which are NOT related to alcohol excess, NAFLD, chronic hepatitis B, C or haemochromatosis.
2. Abdominal/waist circumference greater than 112 cm (44 inches) due to scanner bore constraints
3. Pregnant women.
4. Absolute contraindications for MRI. Any patient that indicates on the MR safety questionnaire that they have or suspect they may have metal in their eye(s) will require an x-ray prior to their MRI scan confirming that their eye(s) are free from metal. This will be verified using previous x-ray records. Any patient whose previous records indicate that they may have had metal in their eye(s) or any patients without any x-ray records will be x-rayed for the purposes of this study. Any patient having current metal in their eye(s), will not be given an MRI scan and therefore will not be recruited into the study.
Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function

All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol.

* All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks.
* Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus patients
* Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy

Exclusion Criteria:

* The use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
* Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
* The use of insulin within the 3 months prior to screening
* Others
Erector Spinae Plan Block for Postoperative Analgesia

Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain afferents in the plane of fascia between transversus abdominis and the internal oblique muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of increased nausea and vomiting, ileus and sedation that may delay hospital discharge.

Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and improve postoperative analgesia.

The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be threaded to extend the duration of analgesia.

Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative pain and opioids consumption.

Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in comparison with the conventional systemic analgesia.


Eligibility Criteria:
Inclusion Criteria:

* 60 ASA I- II adult patients
* 20-60 years old
* elective laparoscopic cholecystectomy
* Body mass index (BMI) less than 35
* Port sites at or above thoracic T 10 dermatome

Exclusion Criteria:

* Allergy to amino-amide local anesthetics
* Presence of coagulopathy
* Local skin infection at the needle puncture sites
* Preoperative chronic dependence upon opioid and NSAID medications
* Liver or renal insufficiency
* History of psychiatric or neurological disease
* Deafness
* previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma
* American Society of Anesthesiologists (ASA) above Class II
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Exclusion Criteria:

* Subjects with a previous or suspected disease caused by N. meningitidis
* previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* previous or suspected disease caused by N. meningitidis
* Any serious acute, chronic or progressive disease
* Pregnant or breastfeeding
E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe

The primary objective is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. This is an open ended prospective non-interventional non-therapeutic multi-cohort study.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed cancer.
* Written informed consent for E²-RADIatE according to applicable legal and ethical requirements
* Planned use of radiotherapy
* Eligibility of the patient confirmed for at least one cohort confirmed
* Patients of 12 years and older
Flexiva Pulse Registry

To obtain post-market safety and efficacy data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).

Multi-center, open label, prospective study to document on-going post-market safety and performance of Flexiva Pulse High Power Single-Use Laser Fibers.

All subjects meeting the enrollment criteria, signing the consent and undergoing the lithotripsy/HoLEP procedure with the study device(s) will be followed: up to 2 months (60 days) post-discharge from final holmium laser lithotripsy procedure for subjects in the lithotripsy cohort or up to 6 months (180 days + 60 days) post discharge from HoLEP procedure for subjects in the Benign Prostatic Hyperplasia (BPH) cohort.

Eligibility Criteria:
Inclusion Criteria:

For Lithotripsy cohort:

1. Subject is undergoing treatment for urinary calculi
2. Subject is willing and able to return for all follow-up visits

For BPH cohort:

1. Subject is ≥ 40 years of age
2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
3. IPSS (International Prostate Symptom Score) ≥ 12
4. Qmax (Peak Flow Rate) ≤ 15 mL/s
5. Subject is willing and able to return for all follow-up visits

Exclusion Criteria:

For Lithotripsy cohort:

1. Subject has uncontrolled bleeding disorders and coagulopathy
2. Subject has untreated urinary tract infection (UTI)
3. Subject requires simultaneous HoLEP procedure

For BPH cohort:

1. Subject has a diagnosis of bladder cancer
2. Subject has a diagnosis of prostate cancer
3. Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy
4. Subject has acute prostatitis, a prostate abscess, or neurogenic bladder
5. Subject has urethral stricture disorder
6. Subject has uncontrolled bleeding disorders and coagulopathy
7. Subject has untreated urinary tract infection (UTI)
8. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter

In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.

In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.

The study subjects will be examined twice, two weeks apart. On the first exam the subject will receive Combigan eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults subjects with no ocular pathology
* Non pregnant women
* Normal pupil response

Exclusion Criteria:

* Chronic topical treatment
* Systemic medication affecting autonomic nerve system
* History of intra-ocular surgery
* Irregular pupil
* History of ocular neurological or severe cardio-vascular disease