cyrilzakka/clinical-trials huggingface dataset:
Eumycetoma Long-term Post-Treatment Follow-Up Study

To assess the long-term recurrence rate of eumycetoma in clinical trial participants treated in the phase II DNDi-FOSR-04-MYC clinical trial.

The purpose of the long-term post treatment follow-up study is to collect data on recurrence of eumycetoma lesions in participants who previously participated in: A randomized, double blind phase II proof-of-concept superiority trial of fosravuconazole 200 mg or 300 mg weekly dose versus itraconazole 400 mg daily, all three arms in combination with surgery, in participants with eumycetoma in Sudan (DNDi-FOSR-04-MYC).

These data will provide additional information on recurrences after end of study (\>15 months) of the parent clinical trial (DNDi-FOSR-04-MYC). The study is observational, since there is no intervention in this protocol, but assesses the outcome of the intervention of the parent trial.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical trial participants who were previously enrolled and received investigational product (fosravuconazole) or standard of care treatment (itraconazole) in the DNDi-FOSR-04-MYC clinical trial.
2. In trial DNDi-FOSR-04-MYC had no recurrence of eumycetoma lesion before month 15.
3. Able and willing to give written informed consent for participation in this study, prior to performance of any study procedures.

Exclusion Criteria:

1. Any condition that, in the opinion of the Principal Investigator or designee, would preclude provision of informed consent or interfere with achieving the study objectives.
SGLT2-inhibitors on PC-AKI

Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI).

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, as a class of oral antidiabetic medications, function by inhibiting SGLT-2, preventing the reabsorption of filtered glucose by the kidneys and thereby increasing glucose excretion in urine. In recent years, a series of studies including EMPA-REG OUTCOME, CREDENCE, DAPA-CKD, DECLARE-TIMI 58, and the CANVAS program have consistently demonstrated that SGLT-2 inhibitors not only effectively improve renal function and slow the progression of chronic kidney disease (CKD), but also significantly reduce the risk of cardiovascular adverse events. Nevertheless, due to their osmotic diuretic effect, SGLT-2 inhibitors can lead to a reduction in renal blood volume within the early phase of application (within two weeks), temporarily augmenting the renal workload and resulting in a decrease in estimated glomerular filtration rate (eGFR).

Consequently, there remains a need to ascertain the specific role of SGLT-2 inhibitors in the prevention of PC-AKI and provide evidence-based support for their application in this context.


Eligibility Criteria:
Inclusion Criteria:

* ACS patients undergoing invasive treatment (PCI or CAG)
* 18 \~ 80 years old adult patients
* Written informed consent provided

Exclusion Criteria:

* Administration of any iodinated CM within 14 days before CAG or PCI
* Hepatic dysfunction (ALT 3 times greater than upper normal limit)
* Thyreoid insufficiency
* Renal artery Stenosis (unilateral \>70％ or bilateral stenosis\>50％)
* Known allergy to any of the study drugs or devices (iodinated CM, etc.)
* Pregnancy or lactation
* Contraindications for the use of SGLT-2 inhibitors, such as severe renal insufficiency (eGFR \<30 mL/min/1.73m2 or currently on dialysis), type 1 diabetes mellitus, severe infection, etc.)
* Any condition which might interfere with study compliance, or otherwise unsuitable for study participation as judged by the investigators
Impact of Papillary Microcarcinoma Terminology on Patients Treatment Preferences: a Cross Sectional Survey

To explore how a clinical sample of patients with thyroid nodules (men and women) with no history of thyroid cancer would make decisions about treatments based on different terminology used to describe papillary thyroid cancer (with and without the cancer term).


Eligibility Criteria:
Inclusion Criteria:

* able to complete a survey

Exclusion Criteria:

* None
Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder

The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder. In a two-armed, randomized controlled trial the efficacy of self-guided psychological intervention delivered via a mobile app (Nałogometr 2.0) will be assessed. During the course of three months, participants will have access to intervention modules, based mainly on mindfulness and cognitive behavioral therapy (CBT). With the use of ecological momentary assessment (EMA), longitudinal data on several variables related to craving and lapse risk will be collected. Additionally, a questionnaire battery assessment - administered monthly - will measure severity of substance dependence, levels of anxiety, depression, and life satisfaction.

The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder.

Participants will be recruited from clinical patients receiving either in-patient or out-patient treatments for Substance Use Disorder (SUD) and enrolled in one of three groups: 1) Patients with alcohol addiction, 2) Patients with cross-addiction (alcohol and stimulants), 3) Patients with cannabis addiction.

Participants will be randomly assigned to either intervention or control condition. The mobile interventions will be delivered via a mobile app Nałogometr 2.0, freely available. Participants in the intervention condition will have free access to all of the app functionalities, while the control group won't gain access to the interventions until after study completion.

Interventions consist of audio-guided, short sessions on gratitude, thoughts management, motivation, relaxation, audio-guided mindfulness sessions concentrated on raising awareness of emotions and body signals or coping with stress, as well as CBT-based written sessions grounded in thought management and journaling techniques.

With the use of ecological momentary assessment (EMA), longitudinal data on several variables related to craving and lapse risk will be collected. Additionally, a questionnaire battery assessment - administered at baseline, after one month, after two months, and after three months - will measure severity of substance dependence, levels of anxiety, depression, and life satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of a Substance Use Disorder (SUD)
* addiction to either alcohol, cannabis, or cross-addiction (alcohol + stimulants)
* min. 18 years of age
* fluent polish speakers
* users of Android or IOS smartphones

Exclusion Criteria:

-
Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia

The goal of this clinical trial is to learn if nebulized colistin can prevent pneumonia in ventilated children. The main question it aims to answer is:

• Does nebulized colistin lower the number of times participants develop ventilation associated pneumonia? Researchers will compare nebulized colistin to a placebo (a look-alike substance that contains no drug) to see if nebulized colistin works to prevent ventilation associated pneumonia in children.

Participants will:

* Take nebulized Colistin or a placebo twice a day for 3 days.
* Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.

The aim of the study is to evaluate the benefit of a 3-day course of inhaled colistin among children undergoing invasive mechanical ventilation for more than 2 days on the occurrence of ventilator-associated pneumonia.

A double-blind, multicenter randomized controlled trial will be conducted. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistin twice daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28.

Eligibility Criteria:
Inclusion Criteria:

* Children older than 1 month and younger than 14 years
* Patients on invasive mechanical ventilation for more than 48 hours
* Informed parental consent

Exclusion Criteria:

* Suspected or confirmed VAP on the day of inclusion
* Indication for systemic colistin therapy before or at enrolment in the study
* Plan for extubation within the next 24H
* Known allergy to colistin
* No parental consent
* Colonization or infection with a germ resistant to colistin on admission
* Tracheostomy
* Appearance of allergic clinical manifestations in the days of colistin nebulization
* Appearance of undesirable clinical or biological manifestations presumed attributable to nebulization with colistin
Individual and Work-Related Risk Factors for Musculoskeletal Pain: a Cross-Sectional Study Among Turkish Office Workers

Most studies investigating the risk factors related with musculoskeletal pain have been conducted in European countries and North America, and because of the difference in health, economic, and social systems, their results are not generalizable to countries such as Turkey. Therefore, the aim of the present study is to investigate the individual and work-related risk factors linked to musculoskeletal pain among Turkish office workers.

A total of 150 participants, who are office workers in Turkey, are included in the present study. Data collection will be carried out using the online survey. The online survey link will be shared via social media accounts and via mail. The questionnaire created through Google forms will be delivered to the participants via the link. The link will be active in the data collection process. Before the participants start the questionnaire, they will be asked whether they were willing to participate. The socio-demographic characteristics (age, gender, body mass index) and health status (presence of chronic disease, drugs used and history of injury) will be questioned. In addition, the information about the sector, working hours, time spent at work and out of work, additional working hours, break times at the workplace will be collected. The Standardized Scandinavian Musculoskeletal Questionnaire will be used to assess musculoskeletal complaints. Participants with musculoskeletal pain will be referred to the assessment questionnaire appropriate for the localization of the region where they feel the most pain. Participants with neck pain will be evaluated with the Neck Disability Scale. Arm-Shoulder-Hand Disability Survey-Short Form will be used for participants with wrist, shoulder or arm pain. Oswestry Disability Index will be used to determine the degree of disability in individuals with low back pain.

Eligibility Criteria:
Inclusion Criteria:

* The participants included in this study will be aged between 18 and 55 years, men or women, an office worker and able to understand and read Turkish as a language.

Exclusion Criteria:

* Participants excluded from the study if they have any musculoskeletal disease, a spine curvature disorders such as scoliosis, kyphosis, kyphoscoliosis, undergone surgery affecting the musculoskeletal system within the last 1 month, or been pregnant for women.
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for Fontan palliation or for surgical repair requiring median sternotomy, will be included in the study.
* Only patients who receive intravenous acetaminophen in the operating room will have serum levels drawn.

Exclusion Criteria:

* Documentation of an allergy to acetaminophen
* Severe hepatic disease or other contraindications to acetaminophen use
* Patient has received acetaminophen within 24 hours of their procedure
Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery

Evaluate the incidence and predictors of post-operative mortality after noncardiac Vascular Surgery and compare the performance of existing risk scores.


Eligibility Criteria:
Inclusion Criteria:

* Elective arterial Vascular Surgery
* Patients \> 18 years

Exclusion Criteria:

* Urgent/Emergent Surgery
* Patients \< 18 years
Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients

The aim of this double blind placebo-controlled study is to evaluate the effect of BIOintestil on fecal microbiota, inflammatory chemokines and symptoms in patients affected by Irritable Bowel Syndrome (IBS).

BIOintestil is a dietary supplement based on Palmrose oil (Cymbopogon martinii) and ginger ryzoma powder. Palmrose oil effects were already established in animal model of colitis and in a pilot study on patients with IBS. In this study, 108 patients will be randomized to receive BIOintestil or placebo in a 1:1 ratio, for four weeks. Fecal and blood samples will be collected at each visit for microbiota and chemokine analysis, patients syntoms will be evaluated by administration of the validated IBS-VAS.

Eligibility Criteria:
Inclusion Criteria:

* willing of sign written informed consent;
* participants affected with Irritable bowel syndrome (IBS) who satisfy Rome III criterias for diagnosis
* body weight between 48 and 104 kg, with a BMI less than 27
* age between 18 and 65 years old

Exclusion Criteria:

* participants that have not taken following medications within 30 days before randomization: steroidal anti-inflammatory drugs, antibiotics or supplemntes or functional foods that may contain probiotics or prebiotics
* women who suspect to be/are pregnant or in lactacy
* participants with Inflammatory bowel disease disgnosis or celiac disease or severe systemic disease
* participants who are intolerant to lactose or with food allergies confirmed
* particpiants with confirmed or suspected hypersensibility to one or more of Bionocol® components
* participants with severe concomitants disease that, by investigator's opinion, interfere with study partecipation
* participants under anticoagulant therapy or with coagulation disease
* participants with renal and hepatic failure
* participants who have taken any investigational drug within 2 month the randomization visit
Impact of the "Kid'EM App" Digital Guidance Tool for Setting Rehabilitation Goals by the Rehabilitation Professional for Children with Chronic Conditions Impacting Physical Health (READ'APP'T)

On an individual level, the first expected benefit for the child using the "Kid'EM app" would be an improvement in the quality of his or her rehabilitation goals, which would be more Specific, Measurable, Activity-related, Realistic and Time-defined (SMART). A second expected benefit for the child, thanks to the work carried out in rehabilitation sessions on objectives adapted to his or her needs and day-to-day life, encouraging commitment and motivation, would be to improve the effectiveness of the care offered to him or her, thereby enhancing autonomy and physical health. For parents, taking part in goal-setting, by contributing their knowledge of their child and his or her daily life, would increase their involvement in their child's care and improve their satisfaction with the care offered. By setting SMART functional goals and facilitating communication between therapist, child and family, we expect to see a more child- and family-centred approach to care.

On a collective level, the "Kid'EM app" proposal would, as recommended by the WHO, improve professional rehabilitation practices and facilitate convergence towards good clinical practices for professionals (physiotherapists, occupational therapists, PRMs, etc.), thereby increasing the efficiency of the child rehabilitation care system.

If its value is demonstrated, the Kid'EM app could be adapted for children with other chronic illnesses requiring non-motor rehabilitation follow-up. The digitization of this goal-setting tool means that this low-cost practice could be widely disseminated.


Eligibility Criteria:
Inclusion Criteria:

* Children with chronic illnesses affecting their physical health (e.g. Cerebral Palsy, Neuromuscular Disease, Brachial Plexus Paralysis, etc.).
* Children receiving rehabilitation care to promote autonomy and physical health.
* Child with at least one rehabilitation session/week with the same professional for a period of 3 months
* Children aged 5 to 17 wishing to participate in the study
* Parental consent for study participation and signature of consent form

Exclusion Criteria:

* Children without chronic illnesses that do not affect their physical health
* Children unable to express their views and priorities
* Children unable to collaborate with the rehabilitation professional when using the Kid'EM app
* Children already familiar with the "Kid'EM app" product
* Children whose parents are minors or unable to give informed consent
Interest of Karate Kata Practice on the Self-esteem of Patients Living With HIV

Since ancient times, physical and sports activity has been recognized as bringing many health benefits. Descriptive and interventional studies on physical activity are developing, demonstrating physical and psychological benefits for patients with various diseases.

Physical activity is effective in improving self-esteem in the general population. Good self-esteem allows for better autonomy to manage a chronic illness.

The benefit of physical activity in patients living with HIV has been the subject of several studies, notably outside France, and seems to improve the quality of life.

We hypothesize that sport, especially karate kata, could improve self-esteem in patients living with HIV, and represent another non-drug aid, in patients living with HIV.


Eligibility Criteria:
Inclusion Criteria:

* patient living with HIV
* Patient seen in the infectious diseases department of Le Mans hospital, during a consultation or day hospitalization for HIV follow-up
* Aged 18 years and older
* Patients able to understand and to give informed consent to participate in the study
* valid social security coverage
* written and signed informed consent by the patient and investigator

Exclusion Criteria:

* refusal to participate to the study
* pregnant or brest-feeding women
* person subject to a legal protection measure
* patient with psychiatric disease
* patient under legal protection
* medical contraindication to play karate kata
Effectiveness of Care Management in Alzheimer Patients

Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence.

Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of Alzheimer disease or associated disorder.

Design and setting: Multicentric cluster randomized control trial. Patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France are included.

Intervention: In addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. This social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. Patient in the control group have absolutely no intervention and are followed-up as usually. In order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation.

Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. Secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease or other dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM IV\] criteria of dementia)
* Presence of an informal caregiver
* Mild to moderately severe dementia (MMSE \[10-28\])
* Diagnosis of dementia made by a specialist ≤ 6 months
* Patient affiliated to the national health insurance system

Exclusion Criteria:

* Institutionalized patient
* Patient on legal guardianship
* Behavioural problem with important clinical repercussion
* Psychotic syndrome
* Severe and unstable general pathology
Treatment of TNNT1-Myopathy With L-Tyrosine.

The purpose of the study is to investigate if treatment with L-Tyrosine improves selected outcome measures of TNNT1 myopathy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* any age with TNNT1-related myopathy

Exclusion Criteria:

* Patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form