cyrilzakka/clinical-trials huggingface dataset:
Ionized Magnesium in Athletes

Ionized magnesium variation is measured during a normal day and again during a day with an exercise protocol of 90 minutes.

Magnesium is an essential micronutrient for health and exercise performance. Deficiencies are common, especially in case of insufficient diets. Athletes are a population at risk of magnesium deficiency, as they can have strong nutritional (dis)believes and increased losses through sweat. That is why monitoring magnesium status in athletes is very important. Ionized magnesium is the active form of total magnesium, this value might be even more important than total magnesium. However, whether ionized magnesium is influenced by day variation is not clear yet. In addition: one bout of exercise can change magnesium status and probably ionized magnesium status. For people active in sports it is important to be aware of this variation in magnesium status, to prevent the diagnosis of false inadequate magnesium status. Therefore it is the aim of this proposal to determine whether ionized magnesium varies within one day and whether it changes after an acute bout of exercise.

Objective:

The main objective is to investigate whether ionized magnesium concentration varies during one day, and whether it is changed after one bout of exercise

Study design:

This will be a cross-over design. With screening and preliminary tests before the exercise test day and the non-exercise test day. The order in which exercise day and non-exercise day will be done, will be randomly divided between the participants.

Intervention:

A rest day and an exercise day At exercise day: an exercise test of 90 min at 70% of VO2max. Blood samples are taken at set time points during rest day and exercise day

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 45 y
* BMI: 18.5 - 25
* Minimal of 5 hours of training per week, for at least 2 years
* Used to bike, at least 5 hours per week in high season
* No Mg and / or Ca supplementation during study
* No blood donation, during or in the 6 weeks preliminary the study
* Suitable veins
* No chronic medication, with the exception of paracetamol and or birth control
* No antibiotics in the month preliminary the study
* Good health
* Serum Mg \> 0.7 mmol/L
* Willing to give blood
* Able to be present and participate at all test days

Exclusion Criteria:

* Chronical illness
* Use of medication with the exception of paracetamol and or birth control
* Mg and or Ca supplementation use
* Inadequate Mg intake (according to FFQ)
* Working at Human Nutrition
* Wageningen University Msc thesis or internship at Human Nutrition
* Participating in other scientific research (with the exception of EetMeetWeet)
Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

Reusable (RU) flexible bronchoscopes (FB) require intermediate level disinfection operations to prevent transmission of infectious agents from patient to patient. These operations have a significant material and human cost and impact their availability in case of emergency. One alternative is the use of disposable FB.

The aim of the study is to evaluate the quality of FB during procedures carried out with each of the two solutions in intensive care unit (ICU), respiratory endoscopy (RE) and anesthesia (A) department.

A prospective non-interventional and non-randomized monocentric study compare the operator satisfaction of therapeutic procedures performed with RU FB (EB FujifilmTM range, FB/FI PentaxMedicalTM range, StorzTM intubation FB) versus disposable FB (aScope 3® and aScope 4® (AmbuTM), Broncoflex® (AxessvisionTM). An evaluation form is completed by the operator at the end of procedure. Judging criteria, rated from 0 to 10, concern handling, ergonomics, image and suction quality.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a therapeutic bronchoscopy (Bronchoalveolar lavage, protected bronchial brushing, suction, difficult intubation)
* Patient followed or treated at the Limoges University Hospital

Exclusion Criteria:

* Patient \< 18 years
* Diagnostic bronchoscopy
* Interventional bronchoscopy
An Individualized Online Home-Based Exercise Program for Improving Symptoms in Disadvantaged Gynecologic Cancer Survivors

This clinical trial tests an individualized online home-based exercise program in disadvantaged gynecologic cancer survivors and its impact on gut microbiome (the bacteria and microorganisms that live in the digestive system) and symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment. These symptoms can significantly reduce the quality of life (QoL) and survival rate in this cancer population. Thus, promoting physical activity among cancer survivors with low SES may help mitigate these severe symptoms. Using online platforms such as Zoom can help participants access an individualized exercise program that meets their specific needs to engage in physical activity and decrease their symptom burden. Home-based exercise, by providing self-chosen time and location and low costs, can address some barriers to physical activity for cancer survivors with low SES. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in disadvantaged gynecologic cancer survivors.

PRIMARY OBJECTIVES:

I. To examine the feasibility and acceptability of an individualized home-based exercise program in gynecologic cancer survivors with low SES.

II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors with low SES.

OUTLINE:

Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the rate of perceived exertion (RPE) scale and receive social support over 30 minutes twice a week (BIW) for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 years old
* Previously diagnosed with gynecologic cancer (e.g., uterine, ovarian, cervical)
* Enrolled in Medicaid (as a factor to determine a low SES)
* Completed cancer treatment (chemotherapy or chemoradiation)
* Able to read and speak English
* Do not meet recommended exercise levels as defined by The American College of Sports Medicine

Exclusion Criteria:

* History of metastatic or other primary cancer
* Serious mental health conditions (e.g., bipolar disorder, schizophrenia, major depression)
* Certain chronic diseases (e.g., muscular-skeletal diseases that limit mobility, autoimmune diseases, uncontrolled diabetes, hypertension, renal disease (creatinine \> 2.5 mg/dL)
* Unable to read/speak English
* Had surgery (including gynecologic surgery) within the past six weeks
* Are currently participating in a regular physical activity program (regular ≥ 3 times/week moderate-intensity exercise)
Development of Non-Invasive MRI Applications for Liver Fibrosis and Inflammation

Chronic liver disease is a major healthcare problem in Hong Kong and worldwide. The diagnosis of liver fibrosis and inflammation in patients with chronic liver disease has important prognostic and therapeutic implications. The current gold standard to evaluate and stage the severity of liver fibrosis and inflammation is based on liver biopsies, which are invasive and impractical for screening and monitoring the disease. The existing non-invasive methods still have significant limitations to meet the challenge.

Magnetic resonance effect can be used to obtain the molecular-level information on the biochemical properties of human tissues. The investigators will develop non-invasive quantitative MRI technologies to evaluate and stage liver fibrosis and inflammation. Our approaches are based on the endogenous contrast mechanism and thus do not need to inject an MRI contrast agent. Our approaches can be implemented on a regular MRI scanner and do not need any extra hardware. To enable the technology for routine clinical use, the investigators will develop fully automated post-processing techniques for the proposed MRI acquisition approaches. The investigators will perform multi-center clinical studies in Hong Kong and mainland China to validate our imaging measurements by histopathologic results from liver biopsies on patient cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Between the age of 18 and 65.
* Chronic liver disease (CLD) patients at different stages of liver inflammation (A0-3) and liver fibrosis (F0-4).
* CLD patients who have indications and are scheduled to undergo liver biopsy.

Exclusion Criteria:

* Patients diagnosed with HCC or other types of cancers.
* Patients who had undergone liver transplantation before enrollment.
* Any contraindications to either liver biopsy or MRI scan.
Social Media Alcohol Intervention

Social media provides frequent interaction with online social networks, increasing exposure to peer influences, which could affect alcohol use in negative or positive ways. The proposed study will recruit adolescents and emerging adults using social media ads, and conduct online screening, enrolling 975 risky drinkers in a randomized controlled trial comparing three conditions: 8-week Social Media Intervention + Incentives, 8-week Social Media Intervention Only, and an e-news attention control condition. These innovative design features will provide the critical next step in harnessing social media to reduce alcohol misuse, which could have enormous public health impact by altering the alcohol use trajectories of youth.

The proposed study will recruit adolescents and emerging adults (ages 16-24) using social media ads and conduct online screening, enrolling 975 risky drinkers (i.e., using AUDIT-C screener) in a randomized controlled trial (RCT) comparing three conditions: 1) Social Media Intervention + Incentives (n=325), 2) Social Media Intervention Only (n=325), and 3) Attention Control E-News condition (n=325), with post baseline follow-up assessments at 3, 6, and 12 months. Interventions will include access for 8 weeks to unique, secret group pages facilitated by e-coaches (supervised by therapists), with dynamic content emphasizing reducing alcohol use/misuse as well as concomitant risk behaviors (other drug use based on co-ingestion and common motives for use).

Eligibility Criteria:
Inclusion Criteria:

Individuals will be eligible to participate if they are between the ages of 16 and 24 years and they have a Facebook account. Additionally, individuals will be eligible if they:

* Have a Past 3-month AUDIT-C score (see below) indicating that they meet criteria for at-risk drinking/alcohol misuse.

  * ages 16-17: ≥3 females and ≥4 males
  * ages 18-24: ≥4 females and ≥5 males

Exclusion Criteria:

* do not live in an area that the study is currently seeking participants from (i.e.- zip code not in area of active recruitment).
* under 16 years of age or over 24 years of age
* not Facebook account holder
* inability to give informed, voluntary consent
Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran

This trial was an obsevational phase IV prospective multicenter study designed to evaluate the safety and effectiveness of Cinnomer® in patients with MS in Iran.

The primary objective of this study was safety assessment of Cinnomer®

Secondary objectives were:

* Effectiveness assessment of Cinnomer®
* Assessment of the patients' QoL
* Evaluation of the patients' depression status

This trial was an observational phase IV prospective multicenter study designed to evaluate the safety and effectiveness of Cinnomer® in patients with MS in Iran.

The primary objective of this study was safety evaluation. To evaluate the safety of Cinnomer®, at each visit, the AEs, seriousness of observed AEs, and abnormal laboratory findings were recorded.

To evaluate the effectiveness of Cinnomer® as the secondary objective, the indicative parameters of MS activity, including relapse information, MRI findings, and EDSS scores were considered. Also, questionnaires assessing the patients' QoL and depression were evaluated.

The sample size of 368 patients and the 14 months of the study was considered applicable for safety and effectiveness evaluation of Cinnomer®, 40 mg/ml, three times per week, in patients with relapsing forms of MS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with RRMS
* Patients diagnosed as SPMS with relapse
* All the patients taking other DMTs and their medication had been changed to Cinnomer® due to any reason.
* 0 ≤ EDSS ≤ 5
* 18 ≤ Age ≤ 60

Exclusion Criteria:

* History of hypersensitivity to Glatiramer Acetate, mannitol, or any component of the formulation.
* In the investigator's opinion, any reason that makes the subject unsuitable for treatment with Cinnomer®.
Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia

A history of preeclampsia is associated with a low plasma volume and higher sympathetic activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the researchers will test that effect on the total cardiovascular balance.

This is a randomized double-blind placebo controlled cross-over study in formerly preeclamptic women with a contracted plasma volume. The researchers will test the effect of methyldopa on the cardiovascular balance and orthostatic tolerance in women with a history of preeclampsia and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous
* History of preeclampsia
* Low plasma volume

Exclusion Criteria:

* Thrombophilia
* Hypertension
* Auto-immune disorder
* Insulin dependent diabetes mellitus
Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source

The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour Holter monitoring.

Covert atrial fibrillation (AF) is a relevant potential cause of a recently proposed clinical construct, "Embolic Stroke of Undetermined Source (ESUS)". However, routine post-stroke work up including 24-hour Holter monitoring may fail to detect paroxysmal AF. A recent systematic review has shown an increased AF detection rate with longer monitoring durations. The aim of this study is to evaluate the effectiveness of a novel ambulatory 7-day Holter ECG (EV-201, Parama-Tech inc.) for detecting AF in patients with recent ESUS after completion of a standard clinical examination.

Eligibility Criteria:
Inclusion Criteria:

1. Recent ESUS (within 3 months of onset) defined as:

   A. Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar B. Abscence of ≥ 50% stenosis or occlusion in cervical and intracranial arteries supplying ischemic area C. No atrial fibrillation after ≥ 24-hour Holter monitoring D. No intra-cardiac thrombus on transthoracic echocardiography E. No other major cardioembolic sources F. No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
2. 20 years of age or older
3. Signed written informed consent

Exclusion Criteria:

1. Previously documented atrial fibrillation
2. Untreated hyperthyroidism
3. Pacemaker or implantable cardioverter defibrillator implanted or planned to implant
4. Estimated life expectancy \< 12 months
5. Examination of seven-day Holter ECG not applicable within 3 months after stroke onset.
6. Patients considered inappropriate to participate in the study
Head Awareness in Chronic Migraine Patients

Research indicates that different beliefs about the nature of back problems and their future consequences direct behaviors that may cause falsely stimulated neuroplastic changes. The central nervous system can help relieve ongoing pain by regulating nociceptive activity. For this purpose, "The Fremantle Back Awareness Questionnaire" was developed to evaluate the perceptual awareness status of the back. In individuals with chronic pain, changes in body perception can be explained by the cortical reorganization that occurs in these individuals. Compared to healthy individuals, cortical thickness is reduced in the brain regions that process pain in chronic migraine patients. On the other hand, it is stated that these cortical structural changes can be reversed and recovery can be achieved by treating headache and related symptoms in chronic migraine patients. Individuals try to continue their daily lives with impaired body awareness due to pain. Decreased awareness has been studied in many neck, back and knee pain studies in the literature with Fremantle Awareness Questionnaires in different societies. In these studies, the awareness of individuals experiencing pain was found to be low and it was found that neck, waist or knee awareness was related to pain intensity, pain catastrophizing, disability, quality of life, anxiety, depression and kinesiophobia. It was even determined that awareness increased with treatments. Although reversible structural changes in the cortical regions of chronic migraine patients have been investigated with radiological imaging methods and are still being investigated, not every patient can be evaluated with radiological imaging in clinics due to cost and time problems. Therefore, a fast, practical and understandable questionnaire evaluation can benefit clinicians. When the literature is examined, there is no study evaluating the perceptual level and nociceptive awareness in chronic migraine headache. Conducting a validity and reliability study of the "Fremantle Headache Awareness Questionnaire" developed from The Fremantle Back Awareness Questionnaire in Turkish society can provide objective results in evaluating the effectiveness of treatment as a practical evaluation method in clinics. Hypotheses:

H0: The Fremantle Headache Awareness Questionnaire is not valid and reliable for the Turkish population in chronic migraine patients.

H1: The Fremantle Headache Awareness Questionnaire is valid and reliable for the Turkish population in chronic migraine patients.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with chronic migraine
* Being between the ages of 18-70,
* Being able to read, speak, understand and write Turkish in order to understand the items/questions of the surveys and scales and to give correct answers.

Exclusion Criteria:

* Having any headache diagnosis other than chronic migraine,
* Having a history of any systemic disease such as malignant, inflammatory, acute fracture/infection, surgery, neurological, psychological, rheumatological.
* Having neck or back pain
Pharmacokinetics of Teicoplanin in Intensive Care and Haematology Patients

Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function.

In a prospective, observational, open-label study the investigators aim to define PK of free drug concentrations of teicoplanine in ICU and heamatology patients and define a PK model for Bayesian dose individualization.

Bacterial infection with coagulase-negative staphylococci (CNS) or methicillin resistant and sensitive staphylococcus aureus(MRSA/MSSA) indicates poor prognosis and increased mortality in critically ill patients.

With the current emergence of glycopeptide-intermediate sensitive Staphylococcus aureus strains, personalized dosing of teicoplanin is of utmost importance to preserve the current therapeutic armamentarium.

Teicoplanin is considered equipotent to vancomycin, albeit safer with minimal nephrotoxicity. It is estimated that 50% of all critically ill patients treated with teicoplanin does not reach target exposure. This is the major driver for treatment failure and development of resistance and dose individualization will overcome this problem.

Our project is aimed at developing and implementing a personalized dosing strategy for teicoplanin, to prevent development of glycopeptide resistance and allow safe treatment of glycopeptide intermediate sensitive bacteria.

In a prospective clinical study, critically ill patients (defined as ICU and hematology patients) who receive teicoplanin as standard care for antimicrobial treatment will be eligible for inclusion. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through an indwelling central venous catheter or an arterial line (9 samples per patient). Teicoplanin total and free drug concentrations will be measured using a validated analytical assay. A total of 30 patients will be included.

We will develop a population PK model using nonlinear mixed effects modelling for total and unbound teicoplanin to characterize the magnitude of inter-individual variability in PK parameters (clearance, distribution volume), and to identify patient-derived characteristics that can predict such variability in a critically ill patient population.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is admitted to the ICU of the haematology department
2. The patient is at least 18 years of age on the day of inclusion
3. Is managed with a central venous catheter or arterial line
4. Is treated with teicoplanin as a part of standard care

Exclusion Criteria:

1. Has previously participated in this study
2. Patient is admitted to the haematology department and receives any form of RRT other than continuous venovenous hemofiltration (CVVH).
Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service

The International Osteoporosis Foundation (IOF) and the American Society for Bone Research and Mineral Metabolism recommend the creation and implementation of fracture coordination services (FLS) as the most efficient way to address the problem. FLS has emerged as a new clinical approach that uses coordinated, multidisciplinary care to improve post-fracture outcomes and reduce recurrent fractures. It is a multidisciplinary and protocolized care model that must guarantee:

1. Identify fragility fractures and people at risk for a fracture
2. Fracture risk assessment
3. Indication for treatment or referral
4. Improvement in therapeutic compliance
5. Reduce the risk of falls It is known that patients who have undergone a FLS model (vs no FLS), have lower mortality, lower risk of fracture, with a reduction of 35% and 56%, respectively, during two years of follow-up. One of the most important objectives of the FLS is the proper recognition and treatment of osteoporosis (OP) in patients with fragility fractures. A major problem is the lack of adherence to treatment for OP, and inclusion in an FLS program increases the prescription of bisphosphonates from 17.9% to 76%. In addition, a specific follow-up program means that 73% of patients followed by FLS continue to undergo anti-resorptive treatment after 2 years of having suffered a femur fracture.

Hypothesis After a femur fracture due to fragility, upon discharge from surgery at the Hospital de la Santa Creu i Sant Pau, including patients in a regional FLS program will make it possible to complete the study of the patient with fracture, improve adherence to treatment of OP (secondary prevention), and obtain better functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* All hip fractures older than 65 years

Exclusion Criteria:

* Politraumatic fractures
* Metastasic fractures