cyrilzakka/clinical-trials huggingface dataset:
Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy

Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding.

The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.

monocentric prospective open-label randomized controlled trial at the ICU of the University Hospitals of Geneva (Switzerland).

ICU patients eligible if they 18 yr old and had an AKI requiring CRRT Exclusion criteria Patients excluded if they had active hemorrhagic disorders or severe thrombocytopenia (\< 50x109/L), a history of heparin-induced thrombocytopenia, severe liver failure defined as a factor V \<20% or were on the waiting list for liver transplantation.

Treatment assignment Subjects enrolled into the trial randomly allocated to either heparin or citrate anticoagulation

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute kidney injury requiring renal replacement therapy (RIFLE criteria)
* Patients (males or females) \> 18 yrs old
* Consent form signed (or in emergency investigator's statement form)

Exclusion Criteria:

* Patients with active bleeding disorders
* Patients with past history of heparin-induced thrombocytopenia (HIT)
* Patients with very severe liver disease ( patients awaiting liver transplant or factor V \< 20% or MELD score \> 25)
* Pregnancy (negative pregnancy test required in child-bearing age women prior to inclusion)
* Enrollment in another concurrent therapeutic trial
Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)

The principle purpose of this multicenter trial is to determine the definition, timing and the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose of the trial is to determine the prevention strategies of further spread of Respiratory Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed RSV infection with either RSV-strip test or polymerase chain reaction (PCR).
* Admission to the NICU or hospitalized in the NICU between 1 October 2013 and 01 April 2014.

Exclusion Criteria:

* Refused informed consent
Cardiac Magnetic Resonance Tomography for Heart Failure With Preserved Ejection Fraction

The diagnosis of heart failure with preserved ejection fraction has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function.However, it is still unclear which parameters can be used meaningfully for diagnostics.To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication for CMR and coronary angiography.

Heart failure with preserved pump function is a common disease that is associated with a high level of suffering for the patient. The diagnosis has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures.

With its high spatial resolution and the possibility of tissue-specific diagnostics, cardiac MRI (CMR) offers outstanding possibilities in cardiac imaging without exposing the patient to ionizing radiation. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function. However, it is still unclear which parameters can be used meaningfully for diagnostics. There is evidence for a correlation with invasively increased LVEDP, although the number of patients examined in the previous studies was still small. In addition, possible influences from medication and clinical parameters were not examined.

To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication. The significance of the study is that in the future CMR could supplement echocardiography in the diagnosis of HFpEF and further reduce the need for invasive diagnostics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CMR and left heart catheterization including LVEDP measurement within the same month

Exclusion Criteria:

* Severe Valve Dysfunction or Pericardial/Pleural Disease
* Contraindictaion for CR or Cath
Long-Term Course of Korean Medicine Treatment for Lumbar Disc Herniation

This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients who received integrative Korean medicine treatment for 24 weeks as part of a previous clinical study.

This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007, and give written informed consent to long-term follow-up assessment at 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007
* Patients who give voluntary written informed consent to long-term follow-up assessment (quantitative and qualitative questionnaires, and MRI) at 10 years.

Exclusion Criteria:

* Patients who cannot give voluntary written informed consent to this study or answer study questionnaires (e.g. severe psychological disorders)
* Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a life expectancy of at least 12 weeks
* Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
* Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen
* Subjects who have an ECOG PS of 0 or 1
* Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria

Exclusion Criteria:

* Primary ocular or mucosal melanoma
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\]\& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 5 years prior to study entry
* History of cardiac disease
* Known history of human immunodeficiency virus (HIV) infection
Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, we conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH.

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, it is urgent to find a method for the early diagnosis of lymphoma-associated HLH. We conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH, and its correlation with disease severity, treatment response, and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-75, gender is not limited.
* Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.
* Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.
* Informed consent obtained.

Exclusion Criteria:

* Patients with severe active infections (viral, bacterial, fungal, or parasitic).
* Patients with active autoimmune disease or a history of organ transplantation who are receiving immunosuppressive therapy.
* Patients with other type of malignant tumors within 5 years, except for cured solid tumors.
* Patients planned to receive immunotherapy.
* Pregnant and breastfeeding females.
* History of human immunodeficiency virus (HIV) infection.
* Acute or chronic active hepatitis B or hepatitis C.
* Patients assessed as ineligible for the study by the investigator.
PERC Health Canada COVID-19

Although there are several licensed vaccines for SAR-CoV-2 (COVID-19) in Canada, none of them are approved for use in children under the age of 12, leaving five million children under 12 years unvaccinated. There is a need to find methods of mass rapid point of care testing in unvaccinated populations such as in schools that can be performed by a lay individual. This multi-center study will evaluate the clinical sensitivity of buccal swabs with the ID NOW COVID-19 device in comparison to standard of care COVID-19 testing at 15 pediatric emergency centres across Canada.

This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. The purpose of the study is to evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19device to detect SARS-CoV-2 infection among children aged 0-\<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as determined by the clinical care team. The study also seeks to identify factors that influence the accuracy of the testing approach and to examine the feasibility and perception of self/caregiver buccal swab sample collection.

In this prospective study, we will validate a self collected buccal swab that is analyzed with the Abbott ID NOW COVID-19 device against a reference RT-PCR nasal, nasopharyngeal (NP) or throat swab (or others) deemed standard of care at participating sites. The standard of care swabs will be collected by a qualified health professional and assessed by local laboratory services.

Individuals presenting to the emergency department that are identified as meeting the criteria as per local guidelines to be tested for SARS-CoV-2 (i.e. droplet precautions) will be appropriately consented and screened for participation in the study.

Eligible, consented participants will have their past medical history, COVID-19 symptom assessment, vaccination status, and physical exam findings collected from their charts.

A qualified healthcare professional will obtain a standard of care RT-PCR Swab from the participant. The results from this swab will be collected from the participants chart once available.

Depending on age, the study team will then train the participant/caregiver how to perform and obtain a buccal swab from the inside of the cheek. The collected buccal swab will be analyzed by the study team using the Abbott ID NOW COVID-19 device and results obtained within approx 15 mins.

Participants and their families will be notified of the qualitative result from the buccal swab.

Participants and their caregivers will be asked to complete pain assessment and acceptability questionnaires for both the standard of care and buccal swab tests.

Eligibility Criteria:
Inclusion Criteria:

1. Age \<18.0 years old
2. Presenting to a participating emergency department
3. Consented to undergo local standard of care SARS-CoV-2 test
4. Able to read/speak English or French

Exclusion Criteria:

1. Inability or unwillingness of individual or legal guardian/representative to give written informed consent or child to give assent.
Outcome of Idiopathic Macular Hole

The purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).


Eligibility Criteria:
Inclusion Criteria:

* Patients with with stage 2, 3, or 4 Idiopathic Macular Hole after successful Idiopathic Macular Hole repair

Exclusion Criteria:

* All patients without stage 2, 3, or 4 Idiopathic Macular Hole repair
Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers

The aim of this study is to determine the prevalence of significant concerns about childbirth and their impact on the course and outcome of childbirth. By identifying a group of mothers who have an excessive fear of childbirth, the occurrence of surgical births can be influenced by the right intervention.

The fear of childbirth is one of the most common mental health concerns during pregnancy. Elevated levels of anxiety during childbirth may lead to increased risk of elective caesarean section or prolonged labour. About 80% of pregnant women suffer from certain kind of childbirth fear. The most commonly used tool for assessment and diagnosis of childbirth fear is Wijma Delivery Expectance Questionnaire (WDEQ). This questionnaire has been translated and validated into several languages. In 2020 the Slovak version of the questionnaire was validated. All women who completed antenatal counseling at 36 weeks of gestation were included in the cohort. A slovak version of questionnaire was issued to all women and the results were recorded in the protocol. Subsequently, demographic data, medical facts and childbirth outcome were added from the medical documentation. The results of the birth were compared with the results of the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* The investigators involve every nullipara and multipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years

Exclusion Criteria:

* unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language, previous Caesarean section (for multipara)
Hepatocyte Growth Factor (HGF) Concentration in Myocardial Infarction

This is the continuation of previous study (registration number: NCT00844987) which revealed that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and prognostic factor for post myocardial infarction (MI) cardiovascular events presence in long-term follow-up. Due to potentially very important implication of the results of previous study it was decided to continue research of HGF in patients with MI. Now, is scheduled to examine 100 consecutive patients with STEMI. HGF assessments will be performed just after admission to hospital, 1h and 24h later and before discharge. Two follow-up visits were planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month visit the echocardiography examination will be performed. The composite primary endpoint consists of cardiovascular events observed during hospital course and in long term-follow-up.

Hepatocyte growth factor (HGF) was examined in study number NCT00844987 as a potentially useful marker of acute myocardial injury. Results of the study confirmed efficacy of HGF as very early marker of myocardial necrosis and as a prognostic factor for cardiovascular events in long term follow up. Recent study is a continuation of previous study.

The aim is to confirm that maximal values of the HGF in first examination performed in ACS (acute coronary syndrome) patients and to show predictive value of HGF for early and late outcome in patients with ACS.

Materials and method: 100 patients with acute coronary syndrome will be included into the study. HGF will be examined four times i.e. just after admission, 1h and 24h latter and before discharge. In case of 10 patients will be performed 10 assessments during first day of ACS.

The follow up visits will take place 3 and 6 months after ACS. During hospitalization and 6 months later echocardiography examination will be performed and the extension of heart dysfunction will be assessed. Control group will consist of 10-15 health volunteers.

The primary endpoint is a composite endpoint which will include following cardiovascular events observed during hospitalization and during 6-month follow up: death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalization due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS.

As a secondary endpoints will be considered: 1) death, 2) symptoms of heart failure 3)rehospitalization due to cardiac events observed during hospitalization or in 6-month follow-up. All this endpoints will consider in context of HGF values and values of routinely measured markers of myocardial injury.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years,
* chest pain,
* symptoms of ischemia at ECG,
* signed informed consent form

Exclusion Criteria:

* age \< 18 years,
* not signed informed consent form.
Comparison of Two Approaches to Weight Loss Follow-Up Study

This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins' diet.

We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.

\*\*\*PLEASE NOTE: Only those who participated in the original study of low carbohydrate and low fat diets are eligable for enrollment in this follow-up study\*\*\*

Eligibility Criteria:
Inclusion Criteria

* Body mass index between 30 and 40
* Live and work within 1 hour of the study site
* Stable psychological status Exclusion criteria
* History of heart disease, heart attack, or stroke
* Blood pressure \>140/90 mmHg
* Abnormal cholesterol levels
* Significant psychiatric illness
* Any medication that affects weight or metabolic rate
* Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
* Currently using antidepressants, steroids, tobacco, or illegal drugs
* Pregnant, breastfeeding, or planning pregnancy
* 10 lb change in weight within 6 months of study entry
* History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
* History of protein wasting diseases or gout
* Severe arthritis
* Osteoporosis
* Certain types of hormone replacement therapy
* Currently following a vegetarian diet
The Diagnostic Validity of the Urea Breath Test

1. To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest and H. pylori culture).
2. To compare the delta value of 13CO2 results between before and after ingestion of citric acid as test meal.

1-1 Screening (visit 1, From -6 to -8 weeks) and H. pylori eradication

1. To accept the agreement, confirm inclusion/exclusion criteria, and evaluate the baseline characteristics of patients
2. H. pylori eradication

   * First eradication: PPI-based triple therapy (standard dose of PPI b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for 1 week), and sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d)
   * Rescue therapy: bismuth-containing quadruple therapy \[PPI b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.\] for 1-2 weeks, or moxifloxacin-containing triple therapy (moxifloxacin 400 mg q.d., amoxicillin 1g b.i.d., and PPI b.i.d.) for 1-2 weeks.

1-2 Baseline (visit 2, 0 week): urea breath test

1. Reconfirm inclusion and exclusion criteria
2. Randomization for UBT test (citric acid group vs control group)
3. In citric acid group: taking 4 g of citric acid solving in 200 ml of water 10 minutes before UBT.
4. Perform UBT in both group

1-3) Endoscopic surveillance (visit 3, 6 or later months)

1. Endoscopic surveillance for final H. pylori status after UBT

   * Histology, CLOtest or H. pylori culture
2. Statical analysis for diagnostic accuracy of the UBT between citric acid group and controlled group: sensitivity, specificity, positive predictive value, negative predictive value, false positive rate, and false negative rate.

2. Selecting 40 patients who showed UBT result between 2.5 to 4.0 in controlled group, the investigators are planning to reperform 13C-UBT after giving citric acid as test meal.

And then, the investigators compare the change of UBT result before and after ingestion citric acid as test meal.

Eligibility Criteria:
Inclusion Criteria:

* Male and female Korean adult (Aged over 18 years)
* The Patients who diagnosed H. pylori infection and received H. pylori eradication therapy

Exclusion Criteria:

* Age under 18 years
* Patients who took any drug which could affect the study results such as proton pump inhibitor, H2 blocker, mucosal protective agents and antibiotics
* Advanced gastric cancer or other malignancy
* Abnormal liver function test or liver cirrhosis
* Abnormal renal function or chronic kidney disease
* Other severe concurrent disease