cyrilzakka/clinical-trials huggingface dataset:
Determination of the Best Positive End-expiratory Pressure (PEEP)

Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome (ARDS) after cardiothoracic surgery

The use of a positive end-expiratory pressure in acute respiratory distress syndrome is obvious in ARDS management. On the one hand it serves to fight against the reduction of functional residual capacity (FRC) and enable the limitation of hypoxia; and on the other hand it allows the limitation of "opening/closing" lesions in pulmonary alveoli which lead to increase "bio trauma".

However elevated PEEP has harmful effect such as hemodynamic effect on the right ventricle and distension on healthy part of the lung.Other adverse effects are: decreasing cardiac output, increased risk of barotrauma, and the interference with assessment of hemodynamic pressures.

Ideally the adjustment of PEEP level must be done by taking into account each patient characteristic. PEEP titration based on blood gas analysis is one of the most used techniques by physicians.

Current guidelines for lung-protective ventilation in patients with acute respiratory distress syndrome (ARDS) suggest the use of low tidal volumes (Vt), set according to ideal body weight (IBW) of the patient, and higher levels of positive end-expiratory pressure (PEEP) to limit ventilator-induced lung injury (VILI). However, recent studies have shown that ARDS patients who are ventilated according to these guidelines may still be exposed to forces that can induce or aggravate lung injury.

Driving pressure (DP) is the difference between the airway pressure at the end of inspiration (plateau pressure, Ppl) and PEEP.

Driving pressure may be a valuable tool to set PEEP. Independent of the strategy used to titrate PEEP, changes in PEEP levels should consider the impact on driving pressure, besides other variables such as gas exchange and hemodynamics. A decrease in driving pressure after increasing PEEP will necessarily reflect recruitment and a decrease in cyclic strain. On the contrary, an increase in driving pressure will suggest a non-recruitable lung, in which overdistension prevails over recruitment.

The main purposes of this study are to assess the optimal PEEP based on the best driving pressure or the best oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* All Patients admitted for intensive care with acute respiratory distress syndrome intubated according to the criteria of the Berlin Consensus

Exclusion Criteria:

* Undrained pneumothoraces
* Hemodynamic instability defined by increased need of vasopressors and / or an systolic arterial pressure below 90 mmHg
* Hypovolemic shock
* Bronchopleural fistula
* High intracranial pressure
Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.

This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time.

Eligibility Criteria:
Inclusion Criteria:

* age older than 45 years
* diagnosis of pituitary adenoma
* treatment-naive with endoscopic endonasal pituitary surgery
* absence of other neurological disease
* absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 45 years
* No diagnosis of pituitary adenoma
* previous treatment with endoscopic endonasal pituitary surgery
* presence of neurological disease
* presence of vitreretinal and vascular retinal diseases
Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.

The investigators want to make genome analysis of tissue samples. This involves analysing the RNA, DNA methylation, for example in cancer cells. This will provide information regarding somatic changes in cancer cells, such as mutations. All of the investigators analysis will be cancer-focused, with the goal of increasing understanding of the heterogeneity.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples. This will then be the miRNA, RNA expression or protein expression in blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastasizing lung cancer where further treatment is still applicable.

Exclusion Criteria:

* Terminal patients or patients in a reduced general condition with EGOC 3-4, i.e. patients who are confined to bed more than 50% of the day, with no clinical indication to perform sampling of the tumor and metastases.
* Patients where further cancer treatment is no longer applicable.
* Patients with cognitive impairment.
* Patients with inaccessible metastases where sampling may cause distress to the patient and are at increased risk of complications.
The Effect of Frailty and Other Geriatric Syndromes on the Prognosis of Elderly Patients With Acute Coronary Syndrome

This is a prospective observational clinical trail which will recruit 1000-1500 participants over 65 years with frailty and acute coronary syndrome (ACS) in Beijing Friendship hospital. The investigators will conduct frailty assessment (FRAIL scale, CFS, SPPB), comorbidities, functional status (Barthel index, ADL, IADL), nutritional risk (MNA-SF), and then observe the clinical outcomes of elderly ACS participants with frailty. Then, the investigators will follow-up these participants separately in 1,3,6 and 12months, the anticipate follow-up time is 1 year. According to the follow-up results, investigators will evaluate the impact of frailty and other senile syndromes on the short-term and long-term prognosis of ACS, and develop a scoring system for the prognosis evaluation of elderly ACS participants.


Eligibility Criteria:
Inclusion Criteria:

* Elderly participants over 65
* Clinical diagnosis of acute coronary syndrome
* Must be able to follow-up
* Sign in the informed consent

Exclusion Criteria:

* Myocardial infarction caused by other acute disease
* Mental disorders who cannot cooperate to complete the assessment
* Severe liver dysfunction, kidney disease (CKD 5), end-stage malignant tumor
* Totally disabled and bedridden
Evaluating Post-test HIV Counseling Videos for Teens

The design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video in educating adolescents about HIV transmission and affecting their intentions to engage in risk-reduction behavior.

Adolescents are at risk for HIV because of their engagement in high risk sexual activity. This study seeks to determine effective ways to educate teens about HIV and how to protect themselves by use of multimedia. All eligible participants who agree to enroll in this trial will be randomized into two arms: the behavioral intervention video (intervention group) or meeting with an in-person counselor (control group) as they wait for their rapid HIV results. The goals of the RCT involve establishing the feasibility of using touch-screen technology for teenagers in the ED; establishing the receptivity of teens to HIV rapid testing in the ED; providing data on rates, and obtaining preliminary data on the effectiveness of the video in changing condom efficacy, condom outcome expectancies and condom use intention. Consenting to rapid HIV testing is a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Youth who have had vaginal, anal or oral sex
2. 15-21 years of age
3. English speaking

Exclusion Criteria:

1. Clinically unstable secondary to pain or unstable vitals signs
2. Unable to understand the consent process for the study
3. Known HIV status or recent HIV test
4. Language other than English
Effectiveness of Massage Applied to Hemodialysis Patients

This study was conducted to determine the effect of massage on comfort and fatigue levels of hemodialysis patients.

Chronic renal failure (CRF) is a health problem that causes significant mortality and morbidity worldwide. The prevalence of the disease is increasing worldwide, especially in developing countries. Hemodialysis (HD) is the most common treatment method for CRF in the world. Approximately 90% of patients with CRF receive HD treatment. Despite advances in technology and medical care due to HD treatment, patients experience many physical and psychosocial symptoms. It is emphasized that comfort is significantly negatively affected in HD patients due to reasons such as the direct impact of HD treatment on the daily and social lives of patients. Increasing the comfort level is important for the patient to continue their daily life activities. In addition, comfort is accepted as the basis of quality nursing care. Increasing the comfort levels of HD patients provides lower comorbidity and mortality rates and improvement in institutional patient outcomes. Fatigue, one of the physical symptoms seen in HD patients, affects 60-95% of patients. Fatigue increases the patients' dependency levels, reduces their physical capabilities, negatively affects the patient and their family economically and reduces their quality of life. Therefore, effective management of fatigue is of great importance for the patient. Despite affecting the patients' lives to this extent, fatigue and discomfort have often been overlooked and neglected symptoms due to their subjective nature. Various pharmacological and non-pharmacological treatment methods are used to control fatigue due to CRF or HD and to bring the desired patient comfort. One of the non-pharmacological methods is massage. Massage can be defined as scientific systematic manipulations applied to body tissues in order to affect the locomotor system and nervous system as well as the general circulation. There are studies in the literature where various applications are applied to HD patients to affect fatigue and comfort. However, it is striking that there is no study examining the effect of massage on the comfort and fatigue levels of patients receiving HD treatment. Therefore, the research was planned to examine the effect of massage on the comfort level and fatigue level of HD patients.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being 18 years of age or older
* Receiving hemodialysis treatment in a dialysis unit for at least six months
* Not having a condition that prevents verbal communication
* Not having a psychiatric problem

Exclusion Criteria:

* Patients who left the study at any stage
* Patients who had been receiving hemodialysis treatment for less than 6 months
Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas

An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.

The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. ESRD receiving hemodialysis in need for new hemodialysis access;
3. Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;
4. Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;
5. Life expectancy ≥ 12 months;

Exclusion Criteria:

1. Life expectancy \< 12 months;
2. Brachial artery stenosis or occlusion;
3. A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);
4. Current immunosuppressive medication, chemotherapy or radiation therapy;
5. Pregnancy or lactation
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females
* Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m\^2)
* Are nonsmokers
* Have normal blood pressure and pulse rate
* Have an electrocardiogram (ECG) considered as within normal limits
* Have clinical laboratory test results within normal reference range

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
* Have known allergies to insulin or its excipients
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Show evidence of significant active neuropsychiatric disease
* Have a history of first-degree relatives known to have diabetes mellitus
* Have a fasting venous blood glucose \>6.0 millimoles per liter (mmol/L)
* Intend to use over-the-counter or prescription medication
* Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

Primary myocardial involvement is common in scleroderma, effected to pericardium, vascular, conducting defect and especially myocardium. Cardiac MRI is widely used for assessment of cardiac involvement in scleroderma, both structural and functional pathology. Cardiac MRI has a diagnostic accuracy of 85% for the detection of myocardial inflammation. Nowadays, the treatment of myocardial inflammation in scleroderma is uncertain. The investigator's study aims to define the cardiac outcome after moderate dose steroid therapy in the patients who have myocardial inflammation detection by cardiac MRI.


Eligibility Criteria:
Inclusion Criteria:

• The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI.

Exclusion Criteria:

* Current infection that needs systemic antibiotic therapy
* Active viral hepatitis B or C
* Uncontrolled diabetes mellitus
Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger

The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be administered at 4 week intervals between doses. The first administration will occur at 6-8 weeks of age.

We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in Niger.

Active surveillance for gastroenteritis episodes will be conducted throughout the trial. Surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age.

To assess the effect of prenatal nutrition supplementation on infant immune response to the BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.


Eligibility Criteria:
Inclusion Criteria:

1. aged 6-8 weeks at the time of inclusion
2. able to swallow and no history of vomiting within 24 hours
3. resident in Madarounfa Health District and within the catchment area of the central health facility
4. intending to remain in the study area for 2 years
5. parent/guardian providing written informed consent

Exclusion Criteria:

Any of the following will exclude an infant from randomization in the study:

1. known history of congenital abdominal disorders, intussusception, or abdominal surgery
2. receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks
3. receipt or planned administration of a blood transfusion or blood products, including immunoglobulins
4. any known immunodeficiency condition
5. any serious medical condition
6. any other condition in which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or the parent/guardian's ability to give informed consent
Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin

Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despite this, there are currently no treatments that delay or halt the development of osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an important factor to consider in the treatment of this condition. Treatments for pain in osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as paracetamol. However, most people with osteoarthritis still have pain despite these treatments.

Recent scientific studies have suggested that people with hand osteoarthritis not only feel pain in their hand joints, they also appear to have increased signals in their brain pain processing pathways. At St George's, University of London, the investigators have been conducting studies to find out which brain regions are activated in subjects with hand osteoarthritis. The investigators have found that certain brain regions (thalamus, insula, cingulate and somatosensory cortex) are activated during painful tasks in patients with hand osteoarthritis but not in healthy people. In this study the investigators will establish whether drugs that inhibit pain processing pathways in the brain can help. Patients who are still having pain despite their usual painkillers will be randomly divided into 3 groups: one group will receive a placebo, the other 2 groups will receive one of two different drugs, duloxetine or pregabalin. Participants will be assessed using questionnaires and a brain scan (functional MRI) before and after 13 weeks of taking the tablets. This study will help us to understand the ways in which people feel pain in osteoarthritis. If our trial proves successful,drugs that dampen central pain pathways could be used in combination with local pain-relieving drugs to improve treatment and reduce disability in patients with hand osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Participants fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis
* Participants with hand osteoarthritis presenting to rheumatology outpatient clinics and primary care.
* Participants will be right or left handed
* Male or female
* Age between 40 and 75
* Participants will be on usual care for hand osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs

Exclusion Criteria:

* Participants with other rheumatological diagnoses e.g. rheumatoid arthritis
* Current or planned pregnancy
* Contraindications to duloxetine or pregabalin
* History of depression
* Recent surgery
* Previous use of duloxetine and/or pregabalin
Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

The study looked at relationship between escitalopram and heart rate variability and QT variability in veterans with PTSD.

The investigators are studying if taking escitalopram will normalize heart rate variability and a decrease (or no effect implying a lack of serious cardiac side effects) including QT variability in veterans with PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria - Group I
* Patients, men and women between 19 and 55 years of age, inclusive.
* Patients with diagnosis of Posttraumatic Stress Disorder as determined by Mini-International Neuropsychiatric Interview (M.I.N.I.).
* Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
* Patients, who signed the written informed consent given prior to entering any study procedure.
* Inclusion Criteria - Group II
* Patients, men and women between 19 and 55 years of age, inclusive.
* Patients with diagnosis of Major Depression as determined by Mini-International Neuropsychiatric Interview (M.I.N.I.). A diagnosis of PTSD will be exclusionary.
* Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
* Patients, who signed the written informed consent given prior to entering any study procedure.

Exclusion Criteria:

* History of cardiovascular disease or a history of hypertension.
* Patients with a concurrent Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis in any of the following categories as determined by the M.I.N.I.
* Lifetime Schizophrenia and Schizoaffective Disorder
* Lifetime Bipolar I Disorder
* Substance Dependence or Abuse (excluding nicotine) within one month prior to the Screening Visit.
* Patients with a history of intolerance or hypersensitivity to escitalopram or citalopram.
* Patients who based on history or mental status examination have a significant risk of committing suicide. Current suicide risk (past month) will be assessed using the M.I.N.I. Suicidality Module. Subjects considered at high suicide risk based on the module (\> 17 points) will be excluded from study participation.
* Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
* Subjects will be excluded who have a history of significant medical illness and who are on medications that affect cardiac and/or autonomic function.
* Female patients who are pregnant, planning to become pregnant, or if of childbearing potential, not using an acceptable method of birth control.