cyrilzakka/clinical-trials huggingface dataset:
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory

Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes.

However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus.

The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.

Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.

Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch model, the Multiple Trace Theory.

Autobiographical memory impairment issue is fundamental for identity construction. Prevent those impairments is important to quality of life improvement after such treatments.

The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.

A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma divided in two groups: the first one with untreated patients and the second one with patients who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study indicated autobiographical memory deterioration in two groups and a worsening in treated group. Study limits did not allow us to draw conclusions. That is why, sample size will be extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators wish to recruit 30 patients with cavernous sinus and meningioma.

Investigators hope for confirm our results from pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35 and 65.
* Patient with:

  * meningioma of the cavernous sinus for which radiotherapy is planned
  * or a pituitary adenoma for which radiotherapy is planned
* French Mother tongue
* Person affiliated to national insurance
* Person who give its verbal agreement to participate

Exclusion Criteria:

* Presence of a serious psychiatric disorder (major depression, psychotic disorders, etc.) and central nervous system disease (epilepsy, multiple sclerosis, etc.).
* Treatment with chemotherapy
* General intellectual abilities deficient (IQ \<80)
* Extension front of their meningioma
* Deficient Language Skills.
Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery

The goal of this observational study is to investigate the role of lactate elevation.

The main aims are:

* Determine the frequency of lactate elevation following pancreatic surgery and its relationship to postoperative complications
* Investigate what patient and surgical related factors that are associated with postoperative lactate elevation This is a retrospective study based on existing medical data and will not affect the medical care of the studied patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pancreatic surgery 2016-2018

Exclusion Criteria:

* Patients unable to undergo scheduled surgery
* Missing data in the postoperative period
Web-based Educational Program Promoting

Elderly abuse is a pervasive and concerning issue, particularly as the global population ages. Gerontological nurses play a pivotal role in identifying, preventing, and responding to elder abuse.

A virtual-based educational program designed to alter nurses' responses to violence against older adults is a comprehensive and interactive initiative aimed at equipping healthcare professionals with the knowledge, skills, and attitudes necessary to address and mitigate instances of violence within this vulnerable demographic. This program leverages digital platforms, incorporating multimedia elements, such as videos, case studies, and interactive simulations, to create an engaging and immersive learning experience. The curriculum is meticulously curated to cover various facets of violence against older adults, encompassing types of abuse, risk factors, identification strategies, and evidence-based intervention techniques.

Key components of the virtual program include scenario-based learning modules that simulate real-world situations nurses may encounter, allowing them to practice appropriate responses in a risk-free environment. Additionally, the program incorporates theoretical frameworks and ethical considerations to guide nurses in understanding the complexities of violence against older adults and formulating empathetic and effective responses.

Interactivity is a focal point, with virtual discussions, forums, and collaborative activities promoting knowledge sharing and peer learning. The program integrates assessments to measure participants' understanding and retention of the material, fostering a continuous learning process.

Moreover, the virtual program emphasizes the importance of interdisciplinary collaboration, encouraging nurses to work in tandem with other healthcare professionals, social services, and law enforcement agencies to create a comprehensive and supportive network for older adults experiencing violence.

Post-program support mechanisms, such as access to resources, expert consultations, and ongoing forums, contribute to sustaining the knowledge gained and fostering a community of practice committed to addressing violence against older adults. Overall, this virtual-based educational program serves as a dynamic and responsive platform, empowering nurses to proactively address and respond to instances of violence against older adults in a holistic and compassionate manner.

Eligibility Criteria:
Inclusion Criteria:

* willingness to enter

Exclusion Criteria:

* entered previous program about elder abuse
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 month to 18 years admitted to the intensive care unit.
* Intubated for more than 48 hours.

Exclusion Criteria:

* Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
* Allergy to chlorhexidine.
* Known immune deficiency.

Elimination Criteria:

* Transfer to another hospital.
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).


Eligibility Criteria:
Key Inclusion Criteria:

* Homozygous for F508del or heterozygous for F508del and an RF mutation (as defined in the protocol).
* Participants with ppFEV1 of ≥70 percentage points adjusted for age, sex, height.
* Participants with a screening LCI2.5 result ≥7.5.
* Participants who are able to swallow tablets.

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension.
* Colonization with organisms associated with a more rapid decline in pulmonary status.
* Solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
Nitric Oxide During Cardiopulmonary Bypass in Neonates to Reduce Risk of Acute Kidney Injury

Acute kidney injury following cardiac surgery for congenital heart defects in children is a major cause of both short- and long-term morbidity and mortality, affecting up to 60% of high risk patients. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Based on preliminary data available in the literature, we hypothesize that nitric oxide (gNO), administered during cardiopulmonary bypass (CPB), may reduce the risk of acute kidney injury (AKI) via mechanisms of reduced inflammation and vasodilation. In this pilot study, 40 neonates undergoing cardiac surgery will be randomized to receive intraoperative administration of 20 ppm of nitric oxide to the oxygenator of the cardiopulmonary bypass circuit or standard CPB with no additional gas.


Eligibility Criteria:
Inclusion Criteria:

* Neonates (≤31 days) undergoing cardiac surgery with cardiopulmonary bypass for congenital heart disease

Exclusion Criteria:

* 1. Failure to obtain informed consent from parent/guardian,
* Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
* Emergency surgery,
* Episode of cardiac arrest within 1 week before surgery,
* Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
* Use of inhaled NO (iNO) immediately prior to surgery,
* Structural renal abnormalities by ultrasound,
* Preoperative AKI,
* Use of other investigational drugs,
* Weight less than \<2.2 kg,
* Gestational age \<36 weeks,
* Major extracardiac congenital anomalies.
Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.


Eligibility Criteria:
Inclusion Criteria:

* Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
* A male or female adult \>= 40 years of age
* Written informed consent to be obtained from the subject prior to study entry
* No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* subject should not be pregnant or plan to become pregnant.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female
* Female planning to become pregnant or planning to discontinue contraceptive precautions
* Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Any confirmed or suspected immunosuppressive or immunodeficient condition
Easy Diabetes Treatment Study 1

A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* ≥ 18 years of age at the time of signing informed consent
* Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening
* HbA1c ≥ 7.0 \[58 mmol/mol\] by central laboratory analysis
* Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)

Exclusion Criteria:

* Previous participation in this trial. Participation is defined as informed consent.
* Currently participating in other clinical trials for diabetes
* Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies
* History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
* Corticosteroid-induced or pancreatitis-induced diabetes
* History of chronic or acute pancreatitis
* Known or suspected substance abuse
* Pregnancy
* Anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins)
* Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg)
* Renal failure stage 5, defined as (estimated or exact) glomerular filtration rate \< 15 mL/min/1.73m2
* Recent or planned major surgery (such as gastric bypass operation)
* Major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel
* Life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)
Cold Application in Lateral Epicondylitis

Purpose: The purpose of this study was to investigate which cold application is more effective to regulate skin temperature in patients with lateral epicondylitis. Materials and Methods: Fifty-four patients with lateral epicondylitis were randomly divided into 2 groups as cooling gel (n=27) group and cold pack (n=27) group. Cooling gel and cold pack applications were applied on painful lateral epicondyle region for 15 minutes. Patients were assessed before and after the application. Assessments included the severity of pain during wrist extension, evaluated by Visual Analog Scale (VAS) and thermal imaging of lateral epicondyle region evaluated by Infrared Thermography (FLIR5 Thermal Camera).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with elbow pain for at least 3 months
* those between 20 and 40 years of age
* who did not have cold allergies

Exclusion Criteria:

* With a different elbow problem or multiple elbow problems,
* having cervical or other upper extremity problems,
* elbow joint operation,
* tendon rupture,
* limited range of motion due to humerus, radius or ulna fracture
* individuals with a history of osteoporosis, malignancy, hemophilia, neurological effect, and cognitive dysfunction
Study of the Vascular Effects of Serelaxin

This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.

double blind, randomized, parallel group, placebo controlled study

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 years of age, with body weight \<160 kg.
* Patients with proven obstructive coronary artery disease, determined either by functional (e.g. treadmill testing) or non-invasive clinical imaging assessments (e.g. stress-echo, PET or SPECT myocardial perfusion), or invasive coronary angiography or by CT coronary angiography at any point in time in patients with or without mild left ventricular systolic dysfunction (LVSD)

Exclusion Criteria:

* Previous treatment with serelaxin (also known as: RLX030, relaxin)
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment.
* Current or planned dialysis.
* Impaired renal function during screening defined as an estimated glomerular filtration rate (eGFR) at screening and prior to treatment of \<30 mL/min/1.73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation due to potential issue with administration of GdDTPA used as the MRI contrast agent.
* Sick-Sinus-Syndrome
* Current or history of pulmonary edema, including suspected sepsis.
* restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function)
* Known significant valvular disease (including any of the following: severe aortic stenosis \[AVA \< 1.0 or peak gradient \> 50 on prior or current echocardiogram\], severe aortic regurgitation, or severe mitral stenosis).
* Clinical diagnosis of acute coronary syndrome (ACS) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria
* Troponin elevation and dynamics indicative of ACS at any time between screening and randomization.
* Previous myocardial infarction within 3 months of screening
* History of Coronary Artery Bypass Graft (CABG) surgery
* Heart failure due to significant arrhythmias (including any of the following: ventricular tachycardia, bradyarrhythmias with ventricular rate \< 45 beats per minute or any second or third degree AV block or atrial fibrillation/flutter with ventricular response of \> 120 beats per minute)
* Any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study (e.g., history of poor tolerance of adenosine or 3 vessel coronary disease)
* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
Fast-Acting Insulin Aspart and Insulin Pump Settings

To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed.

The aim of this study is twofold:

1. to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy.
2. to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for ≥ 5 years
* HbA1c 53-75 mmol/mol (7.0-9.0%)
* Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
* CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
* Carbohydrate counting for all snacks and meals
* Use of the insulin pump bolus calculator for all meals and snacks

Exclusion Criteria:

* Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
* Gastroparesis (clinical assessment)
* Shift work
* Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
* Use of a hybrid closed-loop system
* Use of flash glucose monitoring
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* Chronic paracetamol use
* Alcohol or drug abuse
* Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
* Impaired renal function (eGFR\< 60 ml/min/1.73 m2)
* History of local skin reactions to Fiasp and/or Iasp
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
* Lack of compliance with key study procedures at the discretion of the investigator
* Unacceptable adverse events at the discretion of the investigator
* Less than 40 weeks guarantee remaining on insulin pump
Breathing Exercises for Asthma

Despite the advances in pharmacological therapy for asthma, there has been an increasing worldwide interest in alternative therapies for asthma. Treatments and therapies such as yoga, acupuncture, homeopathy, hypnosis and Buteyko and other breathing techniques have been used as complementary therapies however little evidence exists behind such practices.

Data from systemic reviews and randomized control trials provide evidence of benefit although additional confirmation is still needed. Among the most common techniques are the Buteyko breathing exercises that aim to reduce minute ventilation by instruct asthmatics patients to breathe shallowly and slowly through the nose. The second common technique is the Pranayama, or yoga breathing exercises which emphasizes deep respirations and exhalation prolongation.

Our goal is to assess the effectiveness of breathing exercises as a complementary therapy for asthma.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-65 of either sex, with a physician-diagnosed history of persistent asthma.
* Access to internet

Exclusion Criteria:

* Subjects with history of COPD or any other lung disease, pregnant or lactating women, no access to internet and patients who cannot communicate in English.
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.


Eligibility Criteria:
Inclusion Criteria:

* Japanese participants with WHO grade III or IV malignant glioma
* 70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion
* 80 or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion
* Adequate bone marrow function
* Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2 portion
* Histologically proven newly diagnosed malignant glioma in Arm B and Arm C of Phase 1 portion
* Participants must have confirmed EGFR amplification by central lab in Phase 2 portion

Exclusion Criteria:

* Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2 portion)
* Anti-cancer treatment prior to study Day 1 for Arm B and Arm C of Phase 1 portion
* Participant has received prior treatment with bevacizumabor, EGFR therapy in Arm A of Phase 1 portion and Phase 2 portion, or for recurrent glioblastoma in Phase 2 portion
* Participant has a history of major immunologic reaction to any Immunoglobulin G containing agents or component of ABT-414.