cyrilzakka/clinical-trials huggingface dataset:
Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis

Cystic fibrosis is the most common inherited life limiting condition which affects children. Patients with it develop lung infections which become difficult to clear, and damage the lungs. These are treated with antibiotics (such as tobramycin) into the vein (termed "intravenous antibiotics"). This has without doubt improved survival. However, all treatments have side effects. Tobramycin can cause kidney damage. The investigators have preliminary data that suggests that administering tobramycin in the morning may be safer for the kidneys than administering it in the evening.

The investigators plan to approach children and adults with cystic fibrosis whose doctors have decided to administer a course of intravenous tobramycin. The investigators will randomly allocate them to receive it at either 0800h or 2200h. The investigators will measure the rate at which the body eliminates tobramycin from the bloodstream, by measuring the amount of tobramycin in the blood stream after administering the antibiotic. For each patient the study will last for the duration of the course of antibiotics. This is decided by the doctor looking after the patient (rather than the researcher), and would typically be 14 days. The investigators will also measure substances in the blood and urine ("biomarkers") which are sensitive indicators of low levels of kidney injury. The investigators will monitor lung function and lung bacteria in both the groups to ensure that the patients in both groups improve by the same amount.

If the preliminary data are proved correct, this research will allow investigators to improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis (CF) (defined as clinical features of CF plus a positive sweat test OR the presence of 2 genes known to be associated with CF disease)
* Males or female 5 years and older
* Treating doctor has decided to commence a course of tobramycin
* Patient or parent / legal guardian able to give informed consent

Exclusion Criteria:

* Previous episode of acute kidney injury
* Solid organ transplantation
* Evidence of impaired renal function (raised serum creatinine above the normal range for age)
* Once daily aminoglycoside unsuitable because of hypersensitivity or previous high trough levels on once daily dosing.
* Pregnancy
Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?

Limited pancreatic resections are increasingly performed, but the rate of postoperative fistula is higher than after classical resections. Pancreatic segmentation, anatomically and radiologically identifiable, may theoretically help the surgeon removing selected anatomical portions with their own segmental pancreatic duct and thus might decrease the postoperative fistula rate. Current pancreatic segmentation theories do not enable defining anatomical-surgical pancreatic segments. To our knowledge, no study has tried to describe pancreatic segmentation from the divisions of the pancreatic ducts to date. Hence, we hypothesize to explore the possibility of pancreatic segmentation following pancreatic ducts, using extensive reconstructions of pancreatic duct using micro-scanner on injected human pancreas.

* In a first step, the injection technique will be developed (dilution, stability, hardening of the contrast mixture).
* In a second step, we will inject the mixture in human pancreas: into the duct tree, the vein and arteries. After hardening, the human pancreas will be removed from cadavers following the organ donation technique. The anatomic specimens will be scanned in the laboratory UMR CNRS 7369 MEDyC, Reims (Pr X. MAQUART, Dr J. DEVY).
* The images obtained (Dicom format) are very big in term of file size. Analysis of the images will be performed using a supercomputer of the laboratory CReSTIC - ROMEO EA 3804, Reims (Dr A. RENARD, Pr M. KRAJEKI). 3D reconstructions will be performed.

Eligibility Criteria:
inclusion criteria :

* All consecutive cadavers donated to the Department of Anatomy, Faculty of Medicine and University Hospital, Champagne-Ardenne University for anatomical education and research will be studied. These cadavers will be studied following all the ethical rules of work on cadaver material in our institution.

exclusion criteria :

* Cadavers not usable due to learning necessity, to failure of conservation, dissection difficulties.
Driving Ability Among People With Mild Cognitive Impairment

The Purpose of this study is to assess the effect of MCI on driving ability by using on road driving test. The relationship between their driving outcome and their cognitive decline will be examined.

Each subject will be evaluated by test battery which is accepted to driving assessment and include: The Montreal Cognitive Assessment, Clock Drawing Task, Color Trail Test, Motor Free Visual Perception, Visual Spatial Search Task , Awareness Questionnaire and on road driving test.

The difference between outcome measures of the on road test between the patient group and the control group will be tested. The correlation between outcome measures of the on road test and the cognitive tests will be examined.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Mild Cognitive Impairment(given by a neurologist), valid driver's license and driving experience of at least a year.

Exclusion Criteria:

* people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

The objective of this study is to determine whether the use of postoperative antibiotics following ESS decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CRS with or without nasal polyposis or allergic fungal rhinosinusitis who present to the otolaryngology clinic who have been deemed suitable for bilateral ESS, and are over the age of 18 will be included.

Exclusion Criteria:

* Patients with sinonasal tumors, allergies or adverse reactions to all of the antibiotics that will be used in this study (amoxicillin-clavulanate, doxycycline, clarithromycin), immunodeficiency, cystic fibrosis, pregnancy, or diabetes with nasal polyposis (inability to receive systemic steroids) will be excluded, as will patients who lack capacity to provide informed consent. Patients undergoing active treatment for malignancy will be excluded. Patients undergoing unilateral ESS or with nonabsorbable packing placed at the time of surgery will be excluded. Patients who have been on antibiotics within 2 weeks of the surgery date will be excluded. Patients with acute on chronic sinusitis or the presence of purulence at time of surgery will be excluded from the study.
Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis

The purpose of this study was to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).

This was and open label, parallel group, multicenter, randomized study with 3 clinical periods: Screening period, Treatment period, and Follow-up period.

The design consisted of the Main Study and a Mechanistic Sub study:

1. The Main Study had 2-treatment-arm secukinumab and nb-UVB).
2. The Mechanistic Sub-study had 4 arms treated with secukinumab and one arm with nb-UVB arm. The outcome measures were all exploratory, i.e. no results presented. Not all participants of the Mechanistic Sub-study participated in the Main Study, these participants are only reported for the safety analyses, but not for the primary and secondary outcome measures.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and communicate with the investigator, willing and capable to comply with all study procedures, and provide written signed and dated informed consent (personally or by a witness) before any assessment is performed.
* Aged 18 to 50 years inclusive.
* New-onset plaque psoriasis with appearance of the first psoriasis plaques within the last 12 months before randomization and naïve to any systemic treatment and phototherapy (Arm A1, Arm A2, and Arm B1). Episodes of mild psoriasis, which occurred at least 3 years before screening and resolved spontaneously within 6 months will be accepted.
* Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years or longer and intolerance or inadequate response to phototherapy or any systemic treatment including biologicals, except for IL-17A inhibitors (Arm C1 and Arm C2).
* Moderate to severe plaque psoriasis defined at screening and baseline by PASI \>= 10, and body surface area (BSA) \>= 10%, and IGA mod 2011 \>= 3.

Key Exclusion Criteria:

* Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, and drug induced).
* Ongoing use of prohibited treatments.
* Previous treatment with phototherapy or any systemic treatment.
* Pregnant or nursing (lactating) women.
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the Treatment period or longer if required by locally approved prescribing information (e.g., 20 weeks in the EU and countries where applicable for secukinumab).
The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies

The investigators aim to compare elasticity of the uterine cervix in singleton and twin pregnancies of similar gestational age.

Softening of the uterine cervix occurs during pregnancy.There is a possibility that this process occurs earlier in twin versus singleton pregnancies.The softening of the cervix is reflected by the level of its elasticity which can be measured sonoelastographically. A two dimension image of the cervix is obtained in the midsagittal section and the length is noted. A 2nd sonoelastography image is obtained before pressure is applied with the transducer in the area of the internal os and a third sonoelastography image is obtained until no more shortening of the anterior-posterior diameter is observed.Elastography measurements of the internal os are performed using a color map: red (soft), yellow (medium soft), blue (medium hard) and purple (hard) before and after the application of strain.The change between the color maps before and after strain application in singleton pregnancies will be compared to the change in twin pregnancies of similar gestational age.

Eligibility Criteria:
Inclusion Criteria:

* Low risk singleton and twin pregnancies

Exclusion Criteria:

* Patients with pregnancy complications
The Effect of Biomarkers of Inflammation on Graft Function in Kidney Transplantation

The aim of the study was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* patients underwent renal transplantation

Exclusion Criteria:

* patient refusal
Yearly Strain Variation Study, 2009/2010

The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
* Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
* Subject has given written informed consent prior to study entry
* Subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
* Subject agrees to keep a daily record of symptoms for the duration of the study
* If female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
* Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subject has a history of severe allergic reaction or anaphylaxis
* Subject has an oral temperature of \>= 37.5°C on the day of vaccination in this study
* Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
* Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
* Subject has received a seasonal influenza vaccine within 6 months of study entry
* Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
* Subject has any inherited or acquired immunodeficiency
* Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
* Subject has a functional or surgical asplenia
* Subject has a known or suspected problem with alcohol or drug abuse
* Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
* If female, subject is pregnant or lactating at the time of study enrollment
Oropharyngeal Immunoprophylaxis With High Polyphenolic Olive Oil as Clinical Spectrum Mitigating Factor in COVID-19.

Immunomodulation of local immune response at the oropharyngeal mucosa can hypothetically activate mucosal immunity, which can difficult SARS-CoV-2 main immune evasion mechanisms in early stages of the disease and send an effective warning to the adaptive immune system. There are previous studies on immunotherapeutic management of upper respiratory tract infections with olive polyphenols. The investigators would like to study if participants following oromucosal immunomodulation with tiny quantities of high polyphenolic olive oil (early harvest olive oil) could have more possibilities to have less severe symptoms and a better outcome after SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and non-pregnant women were eligible if they had been in contact of recent COVID-19 diagnosed people and radomly allocated to olive oil group or not treatment at all group.

Exclusion Criteria:

1. Participation in other studies the 6 months before.
2. Pregnant women.
3. Inabilty to oral feeding.
4. Diagnosis of any pathology able to increase risk.
Treadmill Training in Fragile X-associated Tremor/Ataxia Syndrome

A pilot trial to determine the feasibility of treadmill training with dual training in patients with Fragile X-Associated Tremor/Ataxia Syndrome (FXTAS).

There is substantial evidence that physical exercise can improve motor and cognitive function in individuals with Parkinson's Disease, traumatic brain injury or chronic stroke survivors. However, to the investigator's knowledge, no studies have explored the effect of treadmill training with or without a cognitive dual Task on gait, balance and cognition in Fragile X - Associated Tremor/Ataxia Syndrome (FXTAS), which is characterized by action tremor, cerebellar gait ataxia, parkinsonism, peripheral neuropathy and cognitive deficits, all of which increase the risk for falls and progressive disability. There are presently no medications or treatment interventions that have been shown to effectively manage the symptoms of FXTAS or delay disease progression, and it is currently not clear whether either the ST or Dual-Task treadmill training paradigms would be feasible or effective in FXTAS.

A total of 10 individuals with FXTAS will recruited from the Rush University Movement Disorders Clinic or the FXTAS Clinic Database at Rush University. The subjects will be assigned to either 6 weeks of dual-task treadmill exercise training combined with a cognitive task (intervention group) occurring 3 times weekly, or control group. The primary outcome measures will be feasibility, safety and patient adherence. The assessments will occur at baseline, week 3, week 6, 1 month \& 6 month post-training.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of possible, probable or definite FXTAS
* Able to stand and walk without support for 2 minutes

Exclusion Criteria:

* Any neurologic or musculoskeletal problems
* History of traumatic brain injury
* Significant cardiopulmonary or cardiovascular disease
* Dementia or other significant cognitive impairment
* Unstable psychiatric disorders
Evaluating the Effects of Surgical and Non-Surgical Treatment Options in People With Emphysema

Emphysema is a lung disease that involves damage to the air sacs in the lungs and can lead to breathing difficulties. Treatment options for people with emphysema include pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation. This study will observe people with emphysema to assess the effect of these treatment therapies on their quality of life and long-term health.

Emphysema is a progressive lung disease that results in shortness of breath and a reduced capacity for physical activity. It is caused by inflammation within the small air sacs and small airways of the lungs, which can lead to the destruction of the air sac walls and eventually to airway collapse. Treatment options for emphysema include both non-surgical and surgical interventions. Pulmonary rehabilitation, a non-surgical treatment, includes a combination of education, exercise training, nutrition advice, and smoking cessation programs. The goal of pulmonary rehabilitation is to increase exercise tolerance and reduce breathing difficulties. Two surgical treatment options include lung volume reduction surgery, in which small amounts of damaged lung tissue are removed, and lung transplantation, in which a person's damaged lung is replaced with a healthy lung from a donor. While these surgical options may offer potential improvements in quality of life, they also impose substantial risks, including infections, pneumonia, or even death. In this study, researchers will follow participants over a long period of time to assess the effects of pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation on health outcomes and quality of life.

This study will enroll people with moderate to severe emphysema who have undergone pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation. Participants will attend annual study visits and will complete computerized interviews and health-related questionnaires that will assess quality of life factors. Study researchers will also review participants' medical records to collect information on lung function and blood test results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with emphysema
* Referred for pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation

Exclusion Criteria:

* Non-obstructive lung disease
* Chronic obstructive pulmonary disease (COPD) that is not predominantly due to emphysema
* Inability to read English
Continuous Glucose Monitoring During Diets That Differ in Glycemic Load

This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.

The aim of this study is to determine the suitability of a continuous glucose monitor to detect the impact of a dietary intervention on postprandial blood glucose levels in normal, healthy, free living subjects. We will compare a dietary intervention of meals with a high glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low post-meal blood glucose) in a cross-over study. In addition, the glucose profiles obtained both via venous blood sampling and via continuous glucose monitor following a standard carbohydrate load will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy males and post-menopausal females
* Age at start of the study ≥ 50 and ≤ 70 years
* Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2
* Fasting blood glucose value of subjects is ≥ 3.4 and \< 6.1 mmol/L at screening
* Being used to eat three meals a day
* Having a general practitioner
* Agreeing to be informed about medically relevant personal test-results by a physician
* Accessible veins on arms as determined by examination at screening.

Exclusion Criteria:

* Having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician
* Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator
* Use of oral antibiotics in 40 days or less prior to the start of the study
* Reported participation in another nutritional or biomedical study 3 months before the screening or during the study
* Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between mid-night and 6.00 am
* Reported intense sporting activities \> 2h/w. Intense sporting activities are defined as those activities that cause a lack of breath which limits the ability to have a normal conversation
* Reported alcohol consumption \> 10 units/week (female) or \> 14 units/week (male)
* Reported use of any nicotine containing products in the 6 months preceding the study and willing to abstain from use of nicotine containing products during the study itself
* Reported dietary habits: medically prescribed diet, slimming diet, vegetarian
* Reported weight loss/gain (\> 3 kg) in the last 2 months before the study
* Being an employee of Unilever or research departments in NUTRIM or the Maastricht University Medical Centre (MUMC+) collaborating in this study
* Known allergy or intolerance to food products.
* Blood donation in the past 3 months