cyrilzakka/clinical-trials huggingface dataset:
Cognitive Functions on Coronary Surgery

The aim of this study is to examine the effects of different but safe levels of arterial oxygen levels used in cardiac surgeries on cerebral oxygenation during the operation. It is also to investigate the effect on cognitive functions in the postoperative period. For our study the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups according to the arterial oxygen levels.If there is any abnormality in cerebral oxygen levels during surgery, necessary intervention will be made by doctors.

In most cardiovascular surgeries, patients are frequently followed up at hyperoxemic level for safety purposes against the risk of tissue hypoxia that may develop during surgery due to CPB use. At the level of hyperoxemia, there are opinions that the ischemia-reperfusion damage increases with the follow-up of CABG surgery, microcirculation is impaired and tissue oxygenation is impaired due to the resulting hyperoxemic vasoconstriction. Recent research has focused on evaluating optimal oxygen levels in CPB during cardiac surgery. However, the potential of tightly regulated intraoperative normoxia to improve POCD following cardiac surgery has not been studied prospectively.

The purpose of this study is to determine whether patients who underwent CPB and CABG, which were preserved under normoxic conditions during the intraoperative period, would have a lower incidence of early and late POCD than those exposed to hyperoxia.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery

Exclusion Criteria:

* severe preoperative cognitive impairment(i.e. dementia, intellectual disorder)
* Non-Turkish speaking patients
* presence of end-stage organ failure
* patients requiring emergency coronary surgery
* surgical procedures requiring single lung ventilation
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594

The purpose of this study is to evaluate the safety profile and look at levels of AZD7594 and biomarkers in blood when the drug is administered inhaled to healthy subjects

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Ascending Inhaled Doses of AZD7594 in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weight between 50 and 100 kg (inclusive)
* Be able to inhale from the Spira nebuliser used in the study
* Be willing to use a condom with spermicide to prevent pregnancy and drug exposure of a female partner

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Current smokers
* Any clinically relevant abnormal findings
Management in Intensive Care Unit of Life-threatening Keto-Acidosis

Patients hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in participating departments.

Analysis of patients with International Statistical Classification of Diseases and Related Health Problems coding compatible with inclusion

* Selection of patients eligible for inclusion based on review of medical records (verification of inclusion and non-inclusion criteria)
* Telephone contact and sending of the information letter on participation in the study and research of the patient's non-opposition to his participation and the processing of his data.
* Collection of retrospective data
* Phone call to collect prospective data

Eligibility Criteria:
Inclusion Criteria:

* Major (age ≥ 18 years old)
* Hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in the participating departments.
* Diagnosis of ketoacidosis judged to be the main cause of the severity of the clinical condition.
* Blood potential hydrogen \< 7.15 and bicarbonates \< 10mmol/L in the first 12 hours of treatment.
* Presenting at least one of the 3 organ failures during hospitalization among:
* Use of extra-renal purification for acute renal failure
* Administration of pressor amines
* Use of mechanical ventilation

Exclusion Criteria:

* Metabolic acidosis primarily of an origin other than ketonic
* Refusal to participate or opposition to the processing of their data
* Patient under guardianship or curators
A STUDY BEFORE/AFTER THE IMPLEMENTATION OF AN ANTI-INFECTIOUS PRESCRIPTION AID

Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.


Eligibility Criteria:
Inclusion criteria:

* Major patients
* Sepsis or septic shock
* Oral consent

Exclusion criteria:

* minor patients
* death before antibiotherapy
* care limitations
* pre-hospital antibiotherapy
Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes

1. to conduct a clinical investigation to determine if inhaled epoprostenol (Veletri®, iEPO) and inhaled nitric oxide (iNO) will have similar impact on outcomes in adult patients undergoing durable LVAD placement, heart transplantation, or lung transplantation 2. to conduct a cost-capture analysis on the expense each drug incurs per patient.

In adult cardiothoracic surgical patients, iNO is used to treat precapillary pulmonary hypertension (PH), right-sided heart failure (RHF), and ventilation-to-perfusion (V:Q) mismatch. Adult patients who undergo durable LVAD implantation (e.g. Heartware®, Heartmate 2®, or Heartmate 3®), cardiac transplantation for HFrEF, or those that have endured lung transplantation as a result of end-stage lung disease, compose the largest subpopulation which receives iPVD therapy at Duke University Hospital. iEPO may display an equivalent efficacy profile to iNO for pulmonary vasodilation and oxygenation and have a similar impact on clinical outcomes.

Subjects undergoing LVAD placement or heart transplantation (N=224) or lung transplantation (N=200) will be prospectively enrolled over a three-year period (one-year for follow-up). Patients will be randomly assigned 1:1 according to stratified randomization blocking either iNO or iEPO. Additional study procedures will involve data collection, blood, and tissue sampling.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplantation
* LVAD placement
* Lung Transplantation

Exclusion Criteria:

* Combined Organ Transplantation
* Age \< 18 years old
* Pregnancy
* Known allergy to prostaglandin (rare)
* Refusal of blood products due to personal or religious preference
* Subject is enrolled in another study protocol, which does not allow randomization of PVD therapy
* Heart transplant or durable LVAD recipients with adult congenital heart disease (CHD)

  o Caveat: Does NOT meet exclusion criteria if the scheduled heart transplant or LVAD implantation is due to heart failure from a previous heart transplantation related to CHD, performed more than 90 days previous to the date of trial enrollment
* Heart transplant recipients diagnosed with Arrythmogenic Right Ventricular Cardiomyopathy
* Heart transplant recipients diagnosed with Acute Cardiac Allograft Rejection after a previous heart transplantation.
* Heart transplant or durable LVAD recipients with preoperative RVAD for right heart failure
* Patient is scheduled to undergo lung transplantation but has undergone heart transplantation in the previous 90 days
* Patient is scheduled to undergo durable LVAD implantation but has undergone heart transplantation in the previous 90 days
* Patient is scheduled to undergo heart transplantation but has undergone lung transplantation in the previous 90 days
* Patients with preoperative Venovenous ECMO as a bridge to lung transplantation
* Heart transplant or durable LVAD recipients with preoperative RVAD for right heart failure
Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection

Acquiring diarrhoea in hospital is a serious problem and most frequently occurs when susceptible patients receive antibiotics as part of their (often life-saving) care. The commonest cause is Clostridium difficile - a bacterium that normally lives in up to a third of us but causes no problems. Rates of infection had been falling with increased awareness and improved hygiene but they are starting to creep up again. Clostridium difficile can cause a range of disease from a short-lived mild diarrhoea to severe disease of the bowel with major effects on the whole body and even death.

This study aims to identify substances in the stool and in the blood to enable doctors to predict how severe that individual's disease will be. These tests can easily be performed. If they prove accurate in identifying the subsequent severity of the patient's illness due to Clostridium difficile, patients predicted to develop the worst disease can receive the most intensive treatments before they become too unwell to benefit. On the other hand, patients whose disease is predicted by these markers to run its course without causing serious consequences can be spared the side effects and risks of more intensive treatment.

Clostridium difficile infection (CDI), which is often a consequence of antibiotic therapy, is the most common and one of the most serious hospital-acquired illnesses. It causes a range of intestinal upset from mild diarrhoea to a life-threatening severe colitis. The incidence, recurrence and mortality rates of CDI have increased dramatically in recent years. Metronidazole is the recommended first-line antibiotic, with vancomycin and colectomy reserved for severe cases.

Although risk factors for developing CDI are well known, factors that predict outcome and/or recurrence of CDI are uncertain and lack specificity for intestinal inflammation. We wish to investigate if careful prospective monitoring of standard clinical and biochemical measures will be able to identify patients who will go on to fail primary treatment.

If one or more of these factors proves able to predict outcome, they could ultimately be used for early escalation of therapy with the aim of reducing morbidity, mortality and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Test positive for CDI on stool analysis
* Inpatient at Barts Health NHS Trust at time of diagnosis

Exclusion Criteria:

* Nil specific
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure

This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 25-85 years of age, inclusive
* Past diagnosis of hypertension for a min 1 year
* Patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months
* BP is considered adequately controlled with DBP \< 90mmHg
* Elevated BNP levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory
* LV ejection fraction ³ 45%
* LVH defined as myocardial mass ³ 116 g /m2 in males and 104 g/m2 in females
* At least one of the following parameters of diastolic dysfunction

  * E/A \< 1 for the patients who are younger than 55 years or \< 0.8 for the patients whose age is ³ 55 years (full year), or
  * DT \> 220 ms, or
  * IVRT \> 90 ms

Exclusion Criteria:

• Present use of ACE inhibitor

Other protocol-defined exclusion criteria may apply.

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A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.

This is a randomized (study drug assigned by chance), double-blind (neither physician, patient nor the sponsor knows the assigned treatment), placebo-controlled, single and multiple (14 days) ascending dose, parallel group study in 3 study centers (United States, Germany and South Korea). Five cohorts (groups) of patients with Type 2 diabetes mellitus (T2DM) will be studied. One dose level will be evaluated in each cohort. Sixteen (16) patients will be randomly assigned to receive JNJ-28431754 and four (4) patients to receive matching placebo within each cohort. The planned doses are 30, 100, 300 and 600 mg per day. Twice-daily dosing may also be evaluated in one or more of the cohorts. An additional cohort of Asian patients will also be evaluated at a dose level, which was previously tested in a prior cohort and considered to be well tolerated. Blood and urine samples will be collected from patients during the study for pharmacokinetic and pharmacodynamic assessments. The safety and tolerability of JNJ-28431754 will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been diagnosed with Type 2 Diabetes for at least one year before screening
* Patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications
* Males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months)
* Body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2

Exclusion Criteria:

* History of Type 1, brittle diabetes or secondary forms of diabetes
* History of repeated severe hypoglycemic episodes
* History of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis
* History of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the Investigator to be clinically significant
Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

A single-arm, prospective, Phase II, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related GI toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-verified anal cancer
* Eligible for curative intended radiotherapy
* Written and oral consent

Exclusion Criteria:

* Other malignant disease within the past 5 years (excluding basal cell carcinoma)
Generation of Standard Laboratory Values for Pneumococci Antibodies

The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies

This study is meant to determine specific pneumococcal antibodies stratified for age. The investigators also correlate our assay with the results from a commercially available pneumococcal screening ELISA (iGG1 and IgG2) in order to facilitate a screening for immunodeficiency, and to monitor the success of a performed immunization

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing elective surgery

Exclusion Criteria:

* Chronic illness condition,
* Immunodeficiency
ADL- Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)

ADL training of copd patients results in better execution of activities of daily living.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* Referred for rehabilitation
* Age \> 18 years
* Symptoms affecting ADL function
* 6 minute walk distance (6MWD) \< 400 meters

Exclusion Criteria:

* Patients who smokes or has smoked during the last three months.
* LTOT
* Patients who has another disability
* Patients who can't read or speak Norwegian
Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume and Cardiac Output

Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.

Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.

The Cardiac MRI will be received \~1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to undergo Cardiac MRI

Exclusion Criteria:

* Sensitivity to electrodes
Direct Access Physiotherapy in the Pediatric Emergency Department

The goal of this clinical trial is to compare two methods of managing low acuity musculoskeletal complaints in children and adolescents ages 6 to 17.99 years in the pediatric emergency department. The main question it aims to answer is whether delivering care in two methods is feasible. Participants will receive care while in the emergency department and will be followed for a period of 1-month post-presentation.


Eligibility Criteria:
Inclusion Criteria:

* aged 6.00-17.99 years of age
* present to the Montreal Children's Hospital Emergency Department with a suspected MSK complaint, traumatic or not
* are given a triage score of 3 (urgent), 4 (less urgent), or 5 (nonurgent) according to the Canadian Triage and Acuity Scale (CTAS)
* are able to communicate in French or English

Exclusion Criteria:

* present with a major MSK condition requiring urgent care (e.g., open fracture, open wound)
* a red flag (e.g. progressive neurological disorder, infectious symptoms)
* a co-morbid unstable condition.
Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus

The trial evaluates the clinical efficacy and safety of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus. Half of participants will receive autologous osteo-periosteal cylinder graft transplantation, while the other will receive osteochondral graft transplantation as a control group.

Autologous osteo-periosteal cylinder graft surface is a periosteal structure, with the ability of repairment to cartilage, periosteum is closely connected to the cortical bone, then the deep loose cancellous bone.The objective of the study is to evaluate the clinical efficacy of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus by randomized controlled trial. 70 patients with clinically diagnosed Hepple V talus osteochondral lesions according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with autologous osteo-periosteal cylinder graft transplantation under arthroscopy. The control group will be treated with autologous osteochondral graft under arthroscopy. The patients will be treated by the same surgeon in this study group. Postoperative MRI MOCART evaluation, clinical AOFAS score, VAS score, Tegner score, and the secondary arthroscopy ICRS score will be selected as the measures of outcome. The incidence of adverse events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old, male or female
* Chronic pain in the ankle, confirmed by ankle joint MRI as Hepple V osteo-chondral lesions of the talus
* Using rest/external use/oral non-steroidal anti-inflammatory drugs and other conservative treatment for more than 3 months ineffective
* Patients voluntarily participated in clinical trials, signed informed consent, with clinical follow-up

Exclusion Criteria:

* In the last 6 months patients participated in other drug or medical device clinical trials
* Line of force in ankle is not correct (varus or valgus\> 5 degrees)
* Grade III ankle collateral ligament injury
* Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
* Joint fibrosis, ankylosis, activity was significantly limited
* Moderate and severe osteoarthritis
* There are MRI contraindications
* Hemophilia patients
* The general condition of patients can not tolerate surgery
* Pregnant or planned pregnant women and lactating women
* Abnormal mental capacity without autonomy
* Other conditions in which the doctor can not decide to participate in the trial
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of the study drug in male and female patients with end-stage renal disease on hemodialysis. The study consists of a 2 week treatment-free run-in period where entry criteria are verified, a 4-week treatment period, of which the first week of treatment will be performed as an in-patient study in a clinical pharmacology unit (CPU) and the remaining three weeks of treatment will performed as an out-patient study, and a 2-week treatment-free follow-up period.

Safety assessments will be performed at regular intervals and will include clinical and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring. Pharmacodynamic assessments will include, but are not limited to, interdialytic weight gain (IDWG), blood pressure, and stool sodium excretion. Pharmacokinetic assessments will include blood sampling for measurement of study drug plasma concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 80 years, inclusive;
* Body mass index between 18 and 45 kg/m2, inclusive;
* Ambulatory (≥ 6 months) maintenance hemodialysis;
* Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit.

Exclusion Criteria:

* Currently taking diuretic medication;
* Has a urine production of ≥ 200 ml/day (based on a 24-hour measurement starting on Day -1 and completed prior to randomization);
* Predialysis systolic BP \>200 mmHg or diastolic BP \>110 mmHg on two successive occasions during the 2-week run-in period;
* Predialysis SBP \< 110 mmHg on two successive occasions during the 2-week run-in period