cyrilzakka/clinical-trials huggingface dataset:
Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation

The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.

Study Design.

Objective: To determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.

Study Design

* Prospective, randomized, multi-center study of each 1000 subjects enrolled.
* Eligible subjects will be randomized 1:1 to a) atorvastatin 40 mg (n=1000) vs. b) pravastatin 20 mg/day (n=1000). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.
* Subjects with coronary artery diseases who meet all inclusion and exclusion criteria will be included Clinical and laboratory follow-up should be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who had previously received DES at least 12 months(±2month) ago
2. Patients who were free of death, MI, stroke, repeat revascularization, or ST within first 12 months after DES implantation
3. Patients with mono antiplatelet therapy with only aspirin after
4. Age 20 years of older
5. Patients with signed informed consent

Exclusion Criteria:

1. History of DES or BMS implantation within 10 months
2. Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
3. Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
4. Pregnant women or women with potential childbearing
5. Life expectancy ≤ 2 year
A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is \<500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients \>=18 years with moderate to severe active RA for at least 6 months;
* swollen joint count \>=6 (66 joint count) and tender joint count \>=8 (68 joint count) at screening;
* inadequate response to stable dose of MTX;
* patients of reproductive potential must be using a reliable means of contraception.

Exclusion Criteria:

* rheumatic autoimmune disease other than RA;
* patients with functional class IV RA;
* diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
* prior treatment failure with anti-tumor necrosis factor agent;
* pregnant or breastfeeding women.
Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and tolerability of SR121463B in patients with SIADH.

The double blind period is followed by an open label extension study with flexible doses of satavaptan.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years and higher.
* SIADH (the diagnosis of SIADH is based on several criteria including true serum hypoosmolality, inappropriate urinary osmolality, clinical euvolemia, elevated urinary sodium excretion while on normal salt and water intake, and normal renal, adrenal, and thyroid functions: drug induced SIADH will be limited to carbamazepine or derivatives and antidepressants in patients in whom these drugs cannot be discontinued or easily replaced by other drugs)
* Serum sodium between 115 and 132 mmol/L (at least two consecutive serum sodium levels of at least 24 hours apart, from Day -6 to Day -1); for sodium levels between 125 and 132 mmol/L, the spontaneous serum sodium increase between the two assessments on Day -1 should be \< 4 mmol/L
* Urinary osmolality \>200mOsm/kg H2O
* Urinary sodium \> 30 mmol/L

Exclusion Criteria:

* Patients with acute postoperative SIADH
* Presence of dilutional hyponatremia in hypervolemic states such as congestive heart failure and liver disease with ascites
* Presence of signs of hypovolemia (e.g., orthostatic hypotension, increased serum urea nitrogen, increased serum albumin, increased hematocrit, ...)
* Administration of other V2 receptor antagonists or demeclocycline or lithium within one month, thiazides diuretics or spironolactone within 15 days, and urea or loop diuretics within two days prior to study drug administration
* Patients with known treated or untreated adrenal deficiency
* Presence of untreated hypothyroidism
* Presence of uncontrolled diabetes with fasting glycemia \> 200 mg/dL (\> 11.09 mmol/L)
* Presence of clinical and/or electrocardiographical signs of acute myocardial infarction or acute ischemia, or nay other clinically significant abnormality according to the Investigator on a 12 lead ECG recording
* Administration of inducers of CYP3A4, phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitor so CYP3A4within two weeks prior to study drug administration
* Inadequate hematological, renal and hepatic functions: hemoglobin (Hb) \< 9 g/dl, neutrophils \< 1,500/mm3, platelets \<100,00/mm3, serum creatine\>175 µmol/L, ALT and /or AST \>2x upper limit of normal
* QTcB \> 500 ms
* Serum potassium \> 5 mmol/L
Anaesthesia and mHealth

This survey aims to better define the wishes/needs of the Belgian Anaesthesiologists within the field of mobile technology, namely, what would help improve the daily anaesthesia practice.

This study consists of a simple online survey that takes approximately 3 minutes to complete.

The study aims to assess the confidence of the belgian anaesthesiologists on smartphone applications and dedicated smartphone peripherals, on how these can be used in daily practice, as well as what their wishes for further developments are.

Eligibility Criteria:
Inclusion Criteria:

* Active diploma-holding Anesthesiologist working in Belgium

Exclusion Criteria:

* None
Effect of Bariatric Surgery on Kidney Function

Primary hypothesis:

A large reduction in weight is not associated with a change in accurately measured glomerular filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance (51Cr-EDTA)).

Secondary hypothesis:

A large reduction in weight is associated with a greater change in estimated GFR (The Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.

Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately measured GFR.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, older than 18 years of age
* Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark

Exclusion Criteria:

* Withdrawal of surgical indication
* Severe oedema or ascites
Acute Kidney Injury Genomics and Biomarkers in TAVR Study

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.

This study enrolls patients who have aortic stenosis who undergo TAVR at the University of Texas Southwestern Medical Center University Hospital. Development of post-TAVR AKI defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) SCr based criteria will be ascertained. Patients will be followed during primary hospitalization and during the 5 years following TAVR for adverse kidney outcomes as well as potentially related adverse cardiovascular outcomes. Clinical and procedural data is collected for each study patient. All subjects will have paired blood and urine collection done pre-TAVR, 6 hours after aortic valve prosthesis deployment, and on post-procedure days 1 and 2. Subjects who develop AKI will also have paired blood and urine samples collected on days 3, 4 and 5. Patients receive follow-up questionnaires by mail or email asking about hospitalizations as well as visits to cardiology, nephrology and primary care physicians. Questionnaires will also ask about health-related quality of life using validated study questionnaires. Patient follow-up will occur at regular intervals until 5 years after TAVR procedure.

Eligibility Criteria:
Inclusion criteria: Subjects are eligible to participate if they are undergoing TAVR for aortic stenosis at the University of Texas Southwestern Medical Center.

Exclusion Criteria:

1. The patient cannot or will not provide informed consent.
2. The patient is aged less than 18 years.
3. The patient's pre-procedural hematocrit is less than 25%.
4. The patient has known human immunodeficiency virus infection
5. The patient has known hepatitis C that has not been treated with antiviral medications
6. In the opinion of the principal investigator, the patient will be unlikely to complete long-term follow up for medical or social reasons (this includes transient patients and patients who have no fixed address).
Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder

Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of children of BD parents and diagnosed with and BD children whether or not brain has affected zones. These groups were compared to healthy controls and whether or not the mental health of children is influenced will be evaluated by the clinical investigation.

MRI studies in children at risk of BD, our understanding of the neurobiology of BD and abnormalities in the studied regions, regions that predispose to the development of our understanding of PBB will shed light on the etiology of the disorder. In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated. Since there is few studies that evaluate these three groups, there is a need to increase our knowledge on this issue.

Eligibility Criteria:
Inclusion Criteria:

* Children with BD between the ages of 12-18
* Parents with BD who have children between the ages of 12-18
* Healthy children whose parents do not have BD
* Patients who does not have mental or organic disability to answer the questions
* Graduated from primary school

Exclusion Criteria:

* Patients who have mental or organic disability to answer the questions
* Patients who have a history of any chronic disease which is likely to affect the central nervous system
* Patients who have a contraindication for any first application for Magnetic Resonance Imaging (MRI)
Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment

To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification.


Eligibility Criteria:
Inclusion Criteria:

* (18-50) years old with at least 2 sites with gingival recession type (RT1) Cairo Classification (GR with no interdental attachment loss). The interdental CEJ is not detectable clinically on the labial surfaces of the teeth.
* Recession in the maxillary anterior region ≥1 mm of attached gingiva, pocket depth (PD) of \<3 mm, recession depth (RD) ≥2 mm, and gingival index (GI) score ≤1.
* Systemically healthy, willing individuals with good oral hygiene and without contraindications for surgical interventions

Exclusion Criteria:

* the presence of severe systematic diseases or immunodeficiency and contraindicated with surgical interventions.
* Allergies to medicaments used in the treatment process.
* Patients with removable or fixed dentures.
* Patients with cervical abrasion, direct and indirect restorations involving the cervical areas of the maxillary anterior.
* Participants with smoking, tobacco chewing, and alcohol consumption.
* The presence of high frenal attachment and participants who had previously undergone any periodontal surgical procedure or regenerative therapy in the past 1 year at the same site of the planned treatment.
Screening for Obstructive Sleep Apnea in Medical Patients

Obstructive sleep apnea (OSA) is highly prevalent in the general population and is associated with multiple adverse cardiovascular consequences.

Screening for OSA is recommended in those with typical symptoms, such as daytime sleepiness, loud snoring, or abrupt awakenings with gasping or choking. Patients admitted to the general medical wards with these symptoms will be evaluated for the possibility of having OSA.

Obstructive sleep apnea (OSA) is a disease that is highly prevalent in all communities and is associated with adverse cardiovascular events.

Screening for OSA is recommended in men and women who have the typical symptoms, including snoring, daytime sleepiness, or abrupt awakenings with choking or gasping.

OSA screening is also recommended for those with resistant hypertension, bradyarrhythmias, and atrial fibrillation.

Heart failure patients should also be screened for OSA. It is very important to increase the use of OSA screening especially in patients admitted to the medical floor in tertiary care hospitals. No study has evaluated this topic in the Middle East in the past.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign an informed consent
* Patient is admitted to the medical ward in a tertiary hospital

Exclusion Criteria:

* Patients known to have obstructive sleep apnea.
* Patients younger than 18 years of age
Hemodynamic Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension

To study hemodynamic effects of acute normobaric hypoxia during exercise in patients with pulmonary hypertension in a single-center randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Future of the Older Patients After Intensive Care Unit

Estimate the future six months after the admission in an intensive care unit of the patients of 85 and more years old in terms of autonomy.

The diverse studies published on the future of the elderly hospitalized in resuscitation place the limit very low, between 65 and 80 years. The feeling of a very bad forecast at these extreme ages pulls nevertheless a filter in the admission in ICU which has this day no scientific justification. The knowledge of the evolution after the hospitalization of these older patients can help to make certain decisions concerning as well the admission of these patients in ICU as the realization of invasive treatments.

After informal interrogation of numerous intensivists, it seems to take shape a bar around 85 years beyond which the forecast would be worse without more proof what consolidated the choice of this limit.

The reserved scores were already used in similar studies (simplified ALD).

Primary purpose :

* Describe the survival and the evolution of the quality of life after a stay in resuscitation for very old patients.
* The quality of life will be studied through a score of autonomy: the simplified ALD score.

The population will be described in general then by age bracket (more or less of 90 years old), according to the length of stay in ICU, the heavy treatments (artificial ventilation, renal replacement therapy) practiced, the initial gravity (score IGS 2). The impact of possible decisions of Limitation or Stop of Therapeutic Activates will also be taken into account.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 85 years old staying in intensive car units

Exclusion Criteria:

* Knaus D
* No possibly of call (phone) 6 months after ICU admission
* Patients who do not speak French
* Patients do not accept the participation
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related

This is an observational study in which data already collected from people with venous thromboembolism (VTE) due to sepsis (blood poisoning) are studied. These people were hospitalized in an intensive care unit (ICU) and may or may not have had disseminated intravascular coagulation (DIC).

In this observational study, only observations are made without participants receiving any advice or changes to their healthcare.

VTE is a condition that occurs when blood clots form in the veins, which can be dangerous. DIC is a serious blood disorder that can cause clots throughout the body, blocking blood flow. People who have sepsis are at a higher risk of developing both VTE and DIC. Researchers wanted to know if people who have sepsis developed DIC before developing VTE.

To prevent VTE in people with sepsis, it is important to know how severe the sepsis is, how it progresses, and whether DIC is also present or not.

In this study, researchers will assess patient data from a medical database in the United States (US).

The main purpose of this study is to learn if there is a relationship between sepsis, DIC, and VTE.

To do this, researchers will divide the participants with VTE due to sepsis into three groups as follows:

* participants who were diagnosed with DIC based on the extent of blood clotting
* participants who likely had DIC but it was not diagnosed
* participants who did not develop DIC during the same hospital visit

The researchers will collect the following information:

* the number of participants who had VTE due to sepsis also had DIC
* the change in participants' laboratory results and vital signs, such as heart rate and blood pressure, from the time their sepsis was diagnosed to the time their VTE and DIC were diagnosed

The researchers will study the data collected between January 2007 and December 2021.

The data will come from the participants' information stored in a database called the Optum VTE EHR which collects patient medical data from hospitals across the US.

In this study, only available data from routine care are collected. No visits or tests are required as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* admitted to an ICU with the diagnosis of VTE and sepsis during the same hospital ICU admission

Exclusion Criteria:

* less than 18 yrs old
* less than 365 days data available prior to index VTE
Role of Bronchoscope in Diagnosis of Lung Cancer

The study aims to compare the diagnostic yields of bronchial brushing performed before and after forceps biopsy and bronchial wash performed before and after biopsy during flexible bronchoscopy.

Lung cancer is the most common cause of cancer-related mortality in both sexes in the world. To treat the disease successfully, it should be diagnosed at the earliest possible stage. Several studies have demonstrated that early detection, localization, and aggressive treatment of lung cancer result in the 5-year survival rate of 70-80%. Nowadays, bronchoscopy is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been developed using flexible fiber-optic bronchoscopy (FOB).

Bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable diagnostic yields ranging from37-77%. One reason for this variability is limitations in tissue sampling techniques, which can make it impossible to obtain the most representative area of neoplastic tissue. Numerous basic diagnostic procedures using FB, including bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(TBB), and transbronchial needle aspiration, have been evaluated in various combinations to improve the diagnostic yield of FB in patients with suspected lung cancer. However, the optimum sequence of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear and requires further study.

Eligibility Criteria:
Inclusion Criteria:

Patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement.

Exclusion Criteria:

patients with no evidence of malignancy.