cyrilzakka/clinical-trials huggingface dataset:
Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure

The purpose of this study is to establish the accuracy of a non-invasive device that uses near infrared spectroscopy (NIRS) to estimate central venous pressure (CVP) comparing it to physical exam and invasive hemodynamic measurement via right heart catheterization (RHC).

Estimation of volume status is crucial when making treatment decisions for heart failure patients. Volume status is often assessed clinically by estimating the CVP, which is an estimate of right atrial filling pressure, by assessing the level of jugular venous distention. This method is quick and non-invasive but can be prone erroneous measurement due to human error and limitations secondary to body habitus and anatomical variation.

RHC is a procedure used for invasive hemodynamic measurement commonly used in heart failure patients. CVP can be measured directly via RHC using a pulmonary artery catheter. It is considered the gold standard for measuring intra-cardiac filling pressures and calculation of cardiac output and pulmonary and systemic vascular resistance. The obvious downside of RHC is that is invasive, time consuming, and has many potential serious risks including vascular complication, pneumothorax, infection, arrhythmia, valvular damage, etc.

A non-invasive, quick, and accurate way to estimate central venous pressure and oximetry could benefit patient care. NIRS is an optical imaging technology that has been proposed to estimate central venous pressure non-invasively. Our intent is to determine the accuracy of NIRS in assessment of CVP using the Mespere Venus device.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Heart failure patients already receiving RHC as part of their usual care
* Signed written and informed consent

Exclusion Criteria:

* Lack of patient consent
* Presence of known anatomical shunt or AV dialysis fistula
* Sepsis, fever
* Anemia (Hgb \< 10)
* Allergy to adhesive tape
* Known central vein stenosis
* Previous cardiac transplant
* Unable to identify external jugular vein
* Ongoing photodynamic therapy
* Pregnancy
Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis

Systemic sclerosis (SSc) is an autoimmune disease with unknown etiology, which affects especially the gastrointestinal tract, lungs, heart and kidneys. Immunological abnormalities characterized by innate and acquired immune disturbances are associated with the disease development. The present study aims to evaluate the efficacy and safety of probiotics in gastrointestinal symptoms, nutritional status and innate and acquired immune responses, by means of the evaluation of IgA, Treg and Th1, Th2, and Th17 T helper subtypes levels in patients with SSc. In addition the levels of CD4+ T helper Th1, Th2 and Th17 subtypes and Treg levels will be compared to a healthy control group.

Systemic sclerosis (SSc) is a chronic autoimmune disease, which affects the gastrointestinal tract, lungs, heart and kidneys. A shift in the balance between T helper 1 (Th1) and Th2 subtypes and between regulatory T cells (Treg) and Th17 cells levels, as well as intestinal microbiota abnormalities may be present in SSc. These abnormalities can stimulate inflammatory response, and cause intestinal epithelial damage. The use of oral probiotics for microbiome or immune response modulation can be attractive especially in autoimmune diseases. Objectives: To evaluate the efficacy and safety of probiotics in gastrointestinal symptoms, nutritional status and innate and acquired immune responses, by means of the evaluation of IgA, Treg and Th1, Th2, and Th17 T helper subtypes levels in patients with SSc. In addition the levels of CD4+ T helper Th1, Th2 and Th17 subtypes and Treg levels will be compared to a healthy control group. Patients and methods: A randomized double-blind placebo-controlled clinical trial, with 76 SSc patients will be performed. Patients will be randomly assigned to receive oral probiotics once a day or placebo for 8 weeks. The primary outcome will be changes in the gastrointestinal symptoms between baseline and week 8. Clinical evaluation, scleroderma Health Assessment Questionnaire (sHAQ), food intake record, anthropometry assessment and laboratory evaluation will be performed at baseline (T0), at week 4 (T1) and week 8 (T2). C-reactive protein (CRP) and immunoglobulin A (IgA) serum levels assessment will be performed at each visit. The proportion of CD4+ and CD8+ T cells, and Tregs (CD4+CD25+Foxp3+CD127low), and Th1, Th2 e Th17 CD4+ T cell subsets levels will be evaluated using flow cytometer at each visit in SSc patients and also in 50 healthy subjetcs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic sclerosis according to the 2013 ACR/EULAR classification criteria for SSc;
* Patients with gastrointestinal symptoms related to SSc including: gastrointestinal reflux, bloating, diarrhea and constipation;
* Written informed consent provided by the subjects.

Exclusion Criteria:

* Overlap syndromes with systemic lupus erythematosus, polymyositis/dermatomyositis and rheumatoid arthritis;
* Use of antibiotics and/or probiotics four weeks before baseline;
Is Intercostal Tube Enough in Management of Empyema

Is intercostal tube enough in management of empyema ?

Empyema refers to presence of pus in the pleural space -Causes Primary: bacterial Pneumonia (staph aureus, strept pneumonia , H.influenza) , TB

Secondry :

PostTraumati postoperative :open heart , esophageal, mediastinum , lung rupture of lung absess

-pathophysiology and stages During an inflammatory process such as pneumonia, there is an increase in fluid production in the pleural cavity known as the exudate stage. As the disease progresses microorganisms, usually bacteria, can colonize the fluid and generated an empyema. This fluid is characterized by elevated lactate dehydrogenase, proteins, neutrophils, and dead cells. Macroscopically is a thick opaque fluid found in the fibrinopurulent stage. After the resolution of the infection and as a consequence of the inflammation, there is a process of fibrosis that can lead to restriction of the lung parenchyma which is stage of chronic organization

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to Assuit university Hospital and diagnosed with empyema

Exclusion Criteria:

* Patient diagnosed with Post-operative empyema
* Patient diagnosed with post traumatic empyema
* Patient diagnosed with Bronchopleural fistula
* Patient diagnosed with TB
Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer for Normal Adults in South Korea

The human cornea is affected by the magnitude and velocity of both internal and external forces because the cornea has both static and dynamic resistance components. Considering these natures of the human cornea, many investigators have tried to demonstrate corneal biomechanical properties to understand these characteristics of the cornea. Corneal biomechanical properties are known to influence the accuracy of measurements in intraocular pressure (IOP) and are recognized as important factor to explain the susceptibility of development of glaucomatous damage. Until recently, the only instrument which enabled the in vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA, Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the biomechanical properties of the cornea according to the dynamic bidirectional applanation process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology \[Corvis ST\], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer captures the dynamic process of corneal deformation caused by an air puff using an ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now, well-organized analysis on the normative data of the corneal biomechanical profiles measured with the dynamic Scheimpflug analyzer has not been reported yet. Hence, in the present study, we aim to conduct normative data analysis for the corneal biomechanical properties with the dynamic Scheimpflug analyzer in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* Only the participants age \> 20 years old were included
* have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D)

Exclusion Criteria:

* Participants were excluded from analyses if they had abnormal eye-related findings except for clinically insignificant senile cataract, previous ocular or intraocular surgery, glaucoma, history of ocular diseases such as glaucoma or age-related macular degeneration, presence of corneal abnormalities such as keratoconus and forme fruste keratoconus, or corneal scarring that would preclude accurate measurements.
* Participants with diabetes mellitus were also excluded, because of the possible effects of the disease on corneal hysteresis.None of the participants were using eye drops, especially anti-IOP agents, which can change the biomechanical properties of the cornea
Long Term Health Cohort of Premature Infants

Establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and treatment measures and family maintenance environment after discharge on preterm infant mortality and major diseases in the near and long term.

As an increasing large group, the long-term quality of life and health status of preterm infants have become a very important public health problem in China. This cohort study is a single center clinical cohort study. By collecting the clinical diagnosis, treatment and follow-up data of preterm infants admitted to the neonatal department of our hospital for 3 consecutive years (about 1200 cases), and following them for 18 years, a relatively complete resource database for the long-term health and development of preterm infants is established. The effects of perinatal factors, diagnosis and treatment methods and family rearing environment on the survival rate, neurointelligence development, chronic metabolic diseases and respiratory diseases of preterm infants were analyzed. It provides a basis for further improving the diagnosis and treatment plan, exploring potential therapeutic targets and establishing prediction models.

Eligibility Criteria:
Inclusion Criteria:

1. Live born newborns with gestational age ≤ 36 + 6 weeks
2. Transfer to the neonatal ward of Shanghai Children's medical center within 24 hours after birth
3. Those who have lived in Shanghai for more than 1 year and plan to live in Shanghai for a long time. Parents voluntarily participated in the study and signed informed consent

Exclusion Criteria:

1. Premature infants: termination of treatment due to family factors (non-disease reasons) and hospitalization time ≤ 2 weeks
2. Major congenital malformations
3. Parents refuse to participate in the study
Incidence of Hypoglycemia in Pregnant Ladies With or Without Gestational Diabetes Fasting Ramadan

The physiological change in food and sleep pattern during Ramadan impacted hypoglycemia risks among pregnant women. Few studies investigated the incidence of hypoglycemia pregnant women with or without diabetes during fasting in Ramadan in Saudi Arabia. This study aims to understand the glucose variability in pregnant women during fasting Ramadan in Saudi Arabia.

Women with normal pregnancy will be compared to women with gestational diabetes on diet or Metformin alone during Fasting Ramadan. They will be monitored and will be observed for incidence of hypoglycemia using continuous glucose monitoring devices.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old.
2. Pregnant women without diabetes.
3. Pregnant women with diabetes (pregestational and gestational) on diet +/- metformin.
4. Dedicated to applying a continuous glucose monitoring (CGM) device.

Exclusion Criteria:

1. Age below18 years
2. Pregnant women with diabetes on insulin (type 1 and type 2 diabetes)
3. Renal and liver impairment.
4. Adrenal insufficiency
5. Psychiatric diseases.
A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Moderate and Severe RI

* With the exception of RI, is in sufficient health for study participation.
* Has stable renal function.

Healthy

* Matches mean age to participants with moderate and severe RI.
* Has normal renal function.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

All participants

* History of cancer (malignancy).
* Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
* Had a major surgery or lost significant volume of blood within 56 days prior to dosing.
* Donated plasma within 7 days prior to dosing.

Moderate and Severe RI

* Failed renal transplant or had a nephrectomy.
* End stage renal disease requiring dialysis.
* Any significant arrhythmia or conduction abnormality.
* Has non-sustained or sustained ventricular tachycardia.
Chronic Pain Following Thoracic Surgery

Pain that persists after the healing of a surgical wound has previously been described as an important, but often unrecognized clinical problem. Persistent postsurgical (chronic postoperative pain) is the consequence of either ongoing inflammation or more common neuropathic pain as a result of surgical damage to peripheral nerves.

Previous studies have shown that chronic pain is a frequent and serious complication following thoracic surgery. However, the prevalence of chronic pain following both thoracoscopy and anterior thoracotomy in patients with pulmonary malignancies is poorly characterized and the impact of this pain on patients' lives remains unclear. Thus, this study aims to investigate the prevalence of chronic pain following thoracoscopy or anterior thoracotomy, and the severity and impact of persistent post-surgical pain on daily life.

This study is working with several hypotheses: 1.) persistent postsurgical pain following lung cancer surgery is predominantly of neuropathic nature and the presence of neuropathic symptoms increases the severity of postsurgical pain and reduces the patient's quality of life, 2.) the prevalence of chronic pain is reduced over time, and 3.) less invasive thoracic surgical interventions reduces the risk of the development of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients who previously underwent thoracic surgery with lung resection from January 2000 to december 2009

Exclusion Criteria:

* Death
Residual Gastric Content and GLP-1

Studies have shown that even following the fasting guideline, patients on GLP-1 still have residual gastric content which increases their risk of aspiration during anesthesia. We aim to investigate the prevalence of full stomachs following different fasting times.

Glucagon-like peptide-1 (GLP-1) receptor agonists have become increasingly popular as both diabetic and weight loss therapies. One effect of this class of medication is delayed gastric emptying, which may impact the risk of aspiration during anesthesia delivery. Some of them have a very long half-life of approximately one week. Thus, it takes approximately five weeks to achieve its steady-state concentration, and just as long for its effects to terminate after stopping the drug.

As a standard of care, patients are allowed to drink up to 2 hours and to eat up to 8 hours before surgery. Studies have shown that even following the fasting guideline, patients still have residual gastric content which increases their risk of aspiration during anesthesia. Since stopping these drugs for a long time is not practical as it is going to disrupt their glycemic control and reverse the weight loss, we propose to test extending the fasting time.

We aim to investigate the prevalence of full stomachs following different fasting times.

patients will be assigned to one of three groups: Group 1(G1) with 8-hour fasting, Group 2 (G2) with 10-hour fasting, and Group 3 (G3) groups with 12-hour fasting

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 yr. ASA physical status I- III Elective surgery

Exclusion Criteria:

* Pregnancy
* History of upper gastrointestinal disease or previous surgery on the esophagus, stomach or upper abdomen;
* Documented abnormalities of the upper gastrointestinal tract such as gastric tumors; recent upper gastrointestinal bleeding (within the preceding 1 month).
* Medicines that may delay gastric emptying (e.g., anticholinergic agents, opioid)
* ASA class IV or above
* Unable to understand English
* Cardiac cases with low ejection fraction
* Elderly patients above 65 years of age
* Liver or renal transplant cases
* Type 1 diabetes Patients on insulin or sulphonylurea medication
Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.

It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in which 40 procedures to treat one artery (standart) or more than one artery in the same procedure.

The aim of this study is to know if this strategy increase healing velocity and limb salvage.


Eligibility Criteria:
Inclusion Criteria:

* Occlusion of the three arteries bellow the knee previously
* Rutherford 5 - ischemic lesion of the foot
* Informative Term
* At least one patente vessel in pedal arch

Exclusion Criteria:

* allergy to aspirin, clopidogrel or contrast media
* renal impairment
* Tasc D lesion in femoral or popliteal arteries
* no undersatnting patients
Preserve-Transplant Study

The aim of this study is to test if alkali treatment will preserve kidney graft function and diminish the progression of chronic kidney disease in renal transplant patients. Additionally the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in this cohort.

This study is a multi-center, prospective, randomized, single-blind (patient), placebo-controlled interventional trial to test the superiority of alkali treatment in comparison to placebo on preservation of kidney function in 300 kidney transplant recipients. The duration of the study will be 2 years for the individual participant. The patients will be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product: Nephrotrans®) and placebo arm (placebo comparator).

Several studies in CKD (chronic kidney disease) patients have shown that alkali therapy slows progression of CKD.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* age ≥ 18 years and able to give informed consent
* ≥ 12 months after renal transplantation
* stable clinical condition
* stable graft function over the last 3 months (creatinine changes ± 15%)
* eGFR between 15-89 ml/min/1.73 m2
* serum bicarbonate ≤ 22 mmol/l within the last 6 months

Exclusion Criteria:

* uncontrolled hypertension or use of \> 4 antihypertensive agents
* uncontrolled heart failure
* serum potassium \< 3.0 mmol/l
* serum sodium \> 150 mmol/l
* use of alkali in the preceding 4 weeks
* use of mineralocorticoid antagonists, topiramate, carbo anhydrase inhibitors or any drugs with similar effects
* history of noncompliance with clinic visits
* hereditary fructose intolerance
* known hypersensitivity or allergy to the drug used in this study or to peanut, sorbitol, and soy
* pregnancy or breastfeeding
* intention to become pregnant during the course of the study
* lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
* suspected drug or alcohol abuse
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* enrolment of the investigator, his/her family members, employees and other dependent persons
Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims :

* to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
* to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting.

Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims :

* to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
* to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with age ≥ 18 years
* Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 6 months prior to inclusion
* Confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation
* Patients affiliated with a health insurance system
* Able to provide written informed consent.

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breastfeeding
* Patients not affiliated with a health insurance system
* Patient subject to a measure of protection
* Legally protected adults
* Life expectancy \< 3 months