cyrilzakka/clinical-trials huggingface dataset:
Comparison of Total, Salivary and Calculated Free Cortisol Levels in Patients With Severe Sepsis

Background: The purpose of the present study was to compare serum total cortisol (STC), salivary cortisol (SaC) and calculated free cortisol (cFC) levels at the baseline and after the ACTH stimulation test, in patients with severe sepsis (SS) and to determine the suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency in patients with SS.

Methods: Thirty patients with SS (15 men, and 15 women) were compared with 16 healthy controls. Low dose ACTH stimulation test (1 µg) was performed on the first, 7th and 28th days of diagnosis of SS. STC and SaC levels were measured during ACTH stimulation test.

More than 90% of circulating cortisol is predominantly bound to cortisol binding globulin (CBG), but also albumin. Thus, in the presence of both hypoalbuminemia and decreased CBG levels, the ratio of bound to free cortisol levels can be altered. In this situation, measurement of FC becomes more important. Direct FC measurement is time consuming and non-automated. Thus, some indirect methods to determine FC levels had been introduced. The Coolens' method may be practical to determine FC, it estimates FC levels from STC and CBG levels. In patients with CI, the synthesis of CBG and albumin is reduced leading to overestimation of adrenal insufficiency if we only use STC levels. Since some studies demonstrated that salivary cortisol (SaC) reflect free or unbound plasma cortisol levels, this method is used more often in clinical studies. STC and SaC levels at baseline and after ACTH stimulation had been used in some studies in patients with critical illness.

The aim of the present study was to compare STC, SaC and calculated free cortisol (cFC) levels at baseline and after the ACTH stimulation test in patients with SS and determine the suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency in patients with SS. And secondary aims of this study was to compare these parameters in patients with SS with healthy controls and check their effects on survival status of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe sepsis.

Exclusion Criteria:

* Diabetes Mellitus,
* Pregnancy, and
* Use of glucocorticoids of any kind.
Inflammation: Correlates and Prognosis in Framingham

To determine the relation between cardiovascular disease risk factors and systemic markers of vascular inflammation in the Framingham Study cohort.

BACKGROUND:

Recent epidemiologic evidence suggests that inflammation plays a major role in the development of coronary artery disease. High sensitivity C-reactive protein assays have been shown to be independent risk factors for the development of atherosclerosis. Measurements of C-reactive protein also adds to the predictive value of lipid levels in determining the risk of cardiovascular disease. Levels of inflammatory markers may also correlate with response to commonly used lipid lowering agents. The exact role of inflammation in coronary artery disease is not clear; however, it has been suggested that inflammation may be a marker of subclinical cardiovascular disease, or may indicate the presence of vulnerable plaque. In addition to being a possible causative agent in the development of atherogenesis, it has been postulated that inflammatory markers may reflect events that predict the development of myocardial events. The fact that agents such as aspirin and pravastatin, which are known to have anti-inflammatory effects, are effective agents in the prevention of atherosclerosis suggests the possibility that prevention of inflammation may play an important role in reduction of risk for cardiovascular disease.

DESIGN NARRATIVE:

The study assessed inflammatory markers in 3,765 men and women of the Framingham Study. The markers included inflammatory (C-reactive protein, fibrinogen, soluble intercellular adhesion molecule-1, endothelin-1, monocyte chemotactic protein-1, tumor necrosis factor-alpha) and oxidative stress markers (8-epi-PGF 2alpha, thromboxane B2). The relation between CVD risk factors and systemic markers of vascular inflammation was determined. The relations between inflammatory markers, endothelial dysfunction, and subclinical disease were analyzed. Markers of inflammation were related to prevalent and incident cardiovascular disease events adjusting for standard risk factors. The central hypothesis was that inflammatory markers were independent risk factors for cardiovascular disease events with endothelial dysfunction operating in the causal pathway.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)

The objective of this study is to evaluate the effects of 2 intravitreal injections with Ranibizumab or Avastin on endothelial function in subjects with neovascular macular degeneration compared to patients with dry AMD.


Eligibility Criteria:
Inclusion Criteria for active treatment:

* Age: 50 - 80 years
* Diagnosis of neovascular macular degeneration suitable for intravitreal anti-VEGF therapy
* Stable medication for general conditions for at least 1 month
* Written informed consent for participation in the study

Inclusion criteria for controls:

* Age: 50 - 80 years
* Diagnosis of "dry" AMD
* "dry" AMD is defined as at least Age-Related-Eye-Disease-Study (AREDS) category 2 in both eyes and no evidence of neovascularization in either eye
* Stable medication for general conditions for at least 1 month
* Written informed consent for participation in the study

Exclusion Criteria for all subjects:

* Myocardial infarction, unstable angina, stroke within 3 months prior to study entry
* Thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization)
* Uncontrolled symptomatic congestive heart failure (NHYA\> II) in the last 4 weeks prior to study
* Renal insufficiency (Creatinine Clearance \< 50ml/min)
* Ventricular tachyarrhythmias
* Poorly controlled hypertension, defined as resting blood pressure ≥ 160/100 mmHg
* Symptomatic hypotension
* Long acting nitrates
* Smoking (\>5 Zig./d)
* Diabetes mellitus
* Dyslipidemia (LDL-cholesterol \> 4.5 mmol/l)
* Liver disease (ALT or AST \>3x ULN)
* Alcohol or drug abuse
* Hypersensitivity to the active substance or to any of the excipients
* Active or suspected ocular or periocular infections
* Patients with active severe intraocular inflammation
* Malignancy (unless healed or remission \> 5 years)
* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
* Participation in another study within the last month
Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry

The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm.

This is a prospective, single-center study of adult (age ≥18 years) participants undergoing high-resolution esophageal manometry to assess the optimal method of diaphragmatic breathing. Included patients will complete two validated surveys, the Brief Esophageal Dysphagia Questionnaire (BEDQ) and the Gastroesophageal Reflux Disease Questionnaire (GERDQ). Patients will then undergo a standard protocol of supine and upright swallows with high-resolution manometry analyzed according to the Chicago Classification v4.0. After completion of the standard manometry protocol, participants will then perform a protocol assessing different techniques and positions for diaphragmatic breathing.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing high-resolution esophageal manometry

Exclusion Criteria:

* prior esophageal or gastric surgery
* chest tube
* major concomitant illness
* sinus disease precluding manometry placement
* history of heavy alcohol or tobacco use
* poor comprehension and/or fluency of English language
* inability or unwillingness of individual to give written informed consent
Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam

This is a study to investigate the pharmacokinetics of deferasirox


Eligibility Criteria:
Inclusion Criteria:

* Good health
* No evidence of iron deficiency
* Weight between 50 and 100 kg
* Body Mass Index between 19 and 29 kg/m2

Exclusion Criteria:

* Use of certain drugs, herbal remedies or nutrients

Other protocol-defined inclusion/exclusion criteria may apply
Intranasal Insulin Treatment in Patients With Schizophrenia

This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia subjects to examine insulin's effect on psychopathology and cognition. In addition, the study will examine insulin's effects on weight, food intake, resting energy expenditure, and body composition.

The specific aims include:

Primary aims

1. Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
2. Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.

Secondary aims

1. Examine intranasal insulin's effects on weight, food intake and resting energy expenditure.
2. Examine intranasal insulin's effects on body composition, waist circumference, and waist/hip ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years.
2. Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
3. Stable dose of the current antipsychotic drug for at least one month.
4. Well established compliance with outpatient treatment per treating clinician's judgement.
5. Able to complete the cognitive assessment battery (must be English speaking).
6. Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.

Exclusion Criteria:

1. Inability to provide informed consent.
2. Current substance abuse.
3. Psychiatrically unstable per treating clinician's judgement.
4. Significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
5. Pregnancy or breastfeeding.
Doripenem in the Treatment of Complicated Intra-Abdominal Infections

The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. Doripenem or comparator is administered. The primary endpoint is the clinical response measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Has a requirement for surgical intervention within 24 hours of study entry
* Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections

Exclusion Criteria:

* Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control
* Any rapidly-progressing disease or immediately life-threatening illness
Magnetic Resonance Imaging Evaluation of the Tissular Oxygen Saturation in Brain

The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic resonance imaging on subjects and to correlate the results with near infrared spectroscopy measurements.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers or Patients with cerebral lesion

Exclusion Criteria:

* claustrophobia
* MRI exclusion criteria
Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study

In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.

The aim of this study is to investigate the rates and characteristics of patients presenting with acute myocardial infarction between march 1, 2020 to May 31, 2020 and compared those data with those of this year (march 1, 2019 to May 31, 2019).

The following elements will aslo been collected:

* Clinical presentation
* Mode of admission (SAMU (Service d'Aide Médicale Urgente in French ie Emergency Medical Aid Service) / emergency department / in hospital)
* Call for SAMU : delay, number of calls, response
* Thrombolysis
* Delays (symptom onset to first medical contact / door to balloon)
* Final Result : TIMI (Thrombolysis In Myocardial Infarction)
* COVID-19 status if known
* Underlying known ischemic cardiopathy
* ECG (electrocardiogram) Q waves.
* Complication after PCI (Percutaneous Coronary Intervention): Discharged date, LVEF (Left Ventricular Ejection Fraction), ventricular tachycardia Data will be collected through all participating centers under the supervision of the cath lab director.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted on coronary angiography room for acute coronary syndrome with ST segment elevation defined by the following criteria:

* Symptoms suggestive of myocardial ischemia (ex: persistent chest pain) AND
* An elevation of the ST segment (measured from point J) visible on at least two contiguous leads with an elevation ≥ 2.5 millimeters in men \<40 years, or ≥ 2 millimeters in men ≥ 40 years, or ≥ 1.5 millimeters in women in V2-V3 leads and / or ≥ 1 millimeter in other leads (in the absence of branch block).

Exclusion Criteria:

- 121/5000

* Contraindication to invasive management related to the general condition of the patient.
* Minors
* Pregnant women
Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

Given the current emerging epidemic of the MonkeyPox Virus (MPXV) and its route of transmission, the main objective of this pilot study is to characterize the presence of the MPXV in the semen of patients in the acute phase of infection and following this infection.

Since May 2022, a total of 16 000 new cases of Monkey Pox Virus infection has been reported in 76 non-endemic countries. The WHO has declared this epidemic as a public health emergency. Principal routes of transmission are direct skin or mucosa contact or aerosol transmission. The current epidemic mainly affects men having sexual relations with others men and men reporting having recent sexual relations with new or multiple partners. We may wonder if there is a risk of transmission during an intercourse. Moreover, Monkey pox virus infection in human testicle has not been studied yet. Among viruses that infect human semen, some viruses can persist for several months or even years in the semen of cured men. In this context, we propose a research project about the pathophysiology of MPXV in the male genital tract by a clinical approach. Men with a diagnosis of MPXV infection confirmed by a positive PCR and who agreed to be included as volunteer will go to CECOS at Paule de Viguier Hospital, Purpan. Each patient will take a semen and urine sample, have a blood sample and a saliva sample, and a skin sample in case of a lesion; the earliest after the confirmation of the diagnosis of the infection (before the 7th day, the days will be noted) then on Day 15, Day 30, Day 60, Day 90 and Day 180.

Eligibility Criteria:
Inclusion Criteria:

* in the acute phase of MPXV infection and whose PCR reveals the viral genome in a skin sample or in any other sample.
* able to travel to the laboratory for the samples
* who gave his free and informed consent and having signed the consent
* Patient affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Patient who has previously consulted for male infertility or who has previously performed an abnormal semen test (WHO standard)
* Patient with ejaculation disorder or unable to collect semen or with abnormal semen volume (\<1.5 mL).
* Patient who presents serious clinical signs that do not allow him to travel to the investigation center.
* Patient under a protection regime (including guardianship, curatorship or safeguard of justice)
Drug Use Investigation for REVOLADE (ITP)

To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy.

\<Priority investigation item\> Thromboembolism


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

* Not applicable
Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

Fast track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high as 30%, mortality ranges up to 10%. In terms of open infrarenal aneurysm repair no randomized controlled trials exist to introduce and evaluate such patient care programs.

Prospective randomization of patients admitted with infrarenal aortic aneurysm who undergo elective open repair in a "traditional" and "fast track" treatment arm. Main differences consist in preoperative bowel washout (none vs. 3L cleaning solution) and analgesia (patient controlled analgesia vs. patient controlled epidural analgesia: PCA vs. PCEA). Study endpoints are morbidity and mortality, need for postoperative mechanical ventilation and length of stay (LOS) on intensive care unit (ICU).

Eligibility Criteria:
Inclusion Criteria:

* infrarenal aortic aneurysm
* given written informed consent

Exclusion Criteria:

* contraindication for epidural anesthesia
* suprarenal clamping
ITV Extension Study

The objective of this phase I/II therapeutic human immunodeficiency virus (HIV) vaccine candidate study is to provide proof of concept for a HIV antigen delivery system in terms of safety, virological effects and selected immune responses in HIV infected individuals after cessation of antiretroviral combination therapy (ART).

A multi-centre, double-blind, placebo-controlled, 20-week parallel group extension study to the VIR-NCHR-01 protocol (ITV study). The purpose of the extension study is to assess the safety and virological effects of a therapeutic HIV vaccine strategy in HIV-1 infected adults currently enrolled in the ITV study after cessation of antiretroviral therapy. Two active candidate vaccines will be studied in this trial: The active treatment arms will receive recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens or HIV gag-pol antigens and interferon-gamma (IFN-y) in diluent. Vaccines will be delivered by intramuscular injection.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected individuals eligible and still fulfilling the criteria for the VIR-NCHR-01 protocol (ITV study)
* Received all 3 immunisations
* Remained in follow-up for at least 52 weeks
* Continued to take combination antiretroviral therapy with no evidence of treatment failure at the time entering the roll-over phase
* Written informed consent obtained

Criteria for Withdrawal of Study Participants

* Incidental or progression of disease which, in the opinion of the principal investigator, should preclude further study participation
* If the study participant required cytotoxic or immunosuppressive chemo- or radiation therapy
* If the study participant required any medications that when combined with the study vaccination, would in the opinion of the principal investigator, jeopardise the validity of the individual's continued participation
* Administration of prohibited alternative therapy
* Study participant non-compliance
* All study participants are required to adhere to the protocol evaluation schedule. Failure to adhere with this schedule without having first provided justification may result in the participant being withdrawn from the study
* At the request of the study participant or principal investigator without prejudice to future health care
* In the opinion of the investigator, if it is not in the patient's best interests to continue the study
* At the request of the National Centre in HIV Epidemiology and Clinical Research (NCHECR) with reasonable cause
* At the advice of the Data Safety Monitoring Board (DSMB)