cyrilzakka/clinical-trials huggingface dataset:
Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse

Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.

Tissue destructive disorders are more common in smokers than in non-smokers. Alterations in wound healing and connective tissue turnover are suggested mechanisms, but exact details remain to be discovered. The synthesis of subcutaneous collagen in smokers is specifically impeded, and that smokers have less collagen compared to non-smokers. Jorgensen et al study showed that smokers tend to have less procollagen I N-propeptide (PINP) levels in the blood, less vitamin C and higher levels of matrix metalloproteinase (MMP-9), these findings reversed after smoking cessation.

Since smoking is one of the promoting and modifiable factors in the development of prolapse, understanding its effects on the support of pelvic organs may help modify the course of the POP condition in the future. Understanding the connective tissue effects of smoking using systemic markers of collagen metabolism in female smokers with prolapse may help future management and counseling of these patients. In addition, description of the markers of collagen metabolism in POP has not previously been documented.

Eligibility Criteria:
Inclusion Criteria: PROLAPSE group

* More than 18 years old
* Symptomatic POP at or beyond the hymen as determined by physical examination and a positive answer to the screening questions
* For smoker group- smoke more than one pack per day
* For non smoker group- non smoker for more than 7 years

No Prolapse group:

* Absence of prolapse and negative answer to the screening questions

Exclusion Criteria:

* Using Hormone Replacement Therapy (systemic estrogen, progesterone or testosterone)
* Using vaginal estrogen (cream, ring, tablet)
* Chronic steroid use
* Past medical history of connective tissue disease
* Scurvy, malabsorption, alcoholism, pregnancy, hyperthyroidism, liver disease and renal failure
Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm

This study is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland.

Patients will be randomized 1:1 to the brief mindfulness intervention vs neutral audio intervention. The investigators involved in recruitment and testing will be blind to the intervention condition. A collaborator that is not involved in this study will prepare a coded randomized sequence of audio assignments, uploaded in Redcap. The audio will be played on a laptop or mp-player with a noise cancelling headset.


Eligibility Criteria:
Inclusion Criteria:

* We plan to recruit adult female patients (\>18 years old) suffering from fibromyalgia (FMS), with chronic pain (more than 6 months), willing and able to give informed consent. Specifically, patients must fulfil the criteria of the American College of Rheumatology (2010) by having the following combination of scores at the widespread pain index (WPI) and the severity score (SS) :
* WPI score is ≥7 and the SS score is ≥ 5 OR
* WPI score is comprised between 3 to 6 and the SS score ≥9
* And no other condition explaining the painful syndrome

Exclusion Criteria:

* Insufficient French language skills
* Unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose).
* Somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ACE inhibitors or any that would induce a modification in HR)
* Contraindication to sensors positioning (local skin damage or allergies)
* Substance use disorder (alcohol, drugs).
* Refusal to listen to an audio recording of mindfulness
Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy

This study will investigate the impact of music therapy on newly diagnosed patients with cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis Scale).

The purpose of this research study is to examine clinical music therapy's impact on the resiliency of adults undergoing infusion therapy. This research study is being undertaken to learn about how creative music therapy modalities can affect the infusion therapy process. Infusion therapy often includes side effects which impact quality of life. Symptoms include pain, nausea and anxiety. For newly diagnosed patients anxiety accompanies adjustment to scheduling treatments and side effects. Typically patients receiving infusion therapy have no alternative focus for their mind and or body aside from the Infusion itself. Since the relationship between pain and anxiety is inter-related, altering one modality through a live music intervention may modify the impact of the other modality thus shifting the cycle and overall impact of pain and anxiety providing relief which leads to self soothing control measures. The current research will enroll patients newly diagnosed with either Lung, Breast, or Gastrointestinal Cancer that are treated in the Infusion Suite of SLRHC. 100 patients will be randomly assigned to three groups: clinical instrumental improvisation, clinical vocal improvisation or control. All enrolled participants will complete a survey which indicates their music preference, Resiliency Test , the Hospital Anxiety and Depression Scale (HADS), Visual Analogue Scale (VAS), and Body Pain Scale - Color Analysis Scale (CAS).

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* diagnosed with breast cancer, lung cancer, or gastro-intestinal cancer

Exclusion Criteria:

* Under 18
* past cancer(s)
Extended Cross-sectoral Nurse Follow-up After Discharge From a Geriatric Ward - Benefits and Challenges. A Mixed-method Study

Purpose By using both quantitative and qualitative research methods to examine the impact of a coordinated home visit by a geriatric nurse and a community (home care) nurse to vulnerable older patients recently discharged from a geriatric department. The project will address the transition between health care sectors by examining how nursing care information is communicated between sectors, and whether in-home use of digital health solutions can optimize clinical assessments leading to relevant changes in treatment plans and prevention of acute readmissions. User perspectives of both health professionals, patients and their relatives will be applied.

In the quantitative study the primary endpoints are acute readmissions within 30-days and 90-days. The secondary endpoints are 1 year-mortality, numbers of quantitative clinical assessments (e.g., clinical assessment scores, vital signs, POCT) and their associations with clinical decision making, time to readmission, days out of hospital. Financial costs will be assessed.

The qualitative study will provide insight into the challenges and barriers in the transition between hospital and home and opposite as experienced by the patient. Secondly, with a user perspective (i.e. patient, relatives, health professionals) the study will provide in-depth knowledge in the personal care needs of vulnerable patients and how they can be met in a cross-sectoral collaboration between an out-going geriatric nursing team and the home care nursing team. Finally, the important identified complex areas of nursing care during transition will be described and suggested implemented in educational curricula of health professionals.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants are patients acutely admitted to G-OUH, residents in Odense Municipality, and discharged to own home with arranged home care for personal care, or discharged to permanent care in a care home.

Exclusion Criteria:

* Excluded from the study are patients discharged to a temporary skilled nursing facility, terminally ill patients with an anticipated short life expectancy, and incapacitated patients, e.g., patients with a diagnosis of dementia or persistent symptoms of cognitive impairment due to delirium during the whole in-hospital stay. Patients with a permanent address in a care home are not excluded by their type of residence unless they are mentally incapacitated.
Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease

With the accelerating global aging population, dementia has become a pressing worldwide issue. This project aims to identify specific plasma biomarkers and ocular indicators for the early detection of Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged ≥ 50 years;
* Participants diagnosed with Alzheimer's Disease (AD), mild cognitive decline (MCI), subjective cognitive decline (SCD), or cognitively normal (CN);
* Signed informed consent form

Exclusion Criteria:

* Presence of other neurological disorders and systemic diseases that may cause cognitive impairment;
* Inability to cooperate with cognitive assessments;
* Refusal to undergo blood sampling.
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
* Current episode ≥4 weeks.
* CGI-Severity score ≥4 at Screening and Baseline.

Exclusion Criteria:

* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
* Any other current Axis I disorder other than MDD which is the focus of treatment.
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
* Concomitant psychotropic medication, including herbal preparations and melatonin.
* Psychotherapy of any type.
* Prior exposure to agomelatine.
* Female patients of childbearing potential who are not using effective contraception.

Other protocol-defined inclusion/exclusion criteria may apply
Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox

This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute sinusitis with signs and symptoms present for \>7 days but \< 28 days as defined by A), radiographic, and B) clinical criteria, as follows:a. The presence of 1 or more of the following on a radiographic paranasal sinus film (Waters' view) or limited CT scan:\*\* evidence of air-fluid levels\*\* opacification. The presence of at least one major and one minor symptom as defined in the list below:\*\* Major Symptoms\*\*\* Purulent anterior or posterior nasal discharge\*\*\* Unilateral moderate or severe facial pain or malar tenderness\*\* Minor Symptoms\*\*\* Cough or frequent throat clearing\*\*\* Frontal headache\*\*\* Halitosis\*\*\* Fever (oral \> 38.0°C/100.4°F, tympanic \> 38.5°C/101.2°F)\*\*\* Purulent secretions obtained via middle meatus secretion sampling using nasal endoscopic technique; the specimen sent for Gram stain, culture and susceptibility testing prior to initiation of antimicrobial therapy

Exclusion Criteria:

* History of chronic sinusitis defined as greater than four weeks of continuous symptoms (patients with history of sinus surgery may be included; patients with recurrent sinusitis may be included)
* Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses- Received systemic antibacterial therapy likely to be effective in sinusitis for more than 24 hours within 7 days of enrollment- A requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol- Known immunodeficiency diseases including AIDS (CD4 \<200)- On topical nasal or systemic corticosteroids, unless they have been on a stable dose for \> 4 weeks prior to enrollment- History of allergy to quinolone antibiotics or related compounds- Pregnant or breast feeding- Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
* Received an investigational drug in the past 30 days- Unable to take oral medication- Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
* End stage liver cirrhosis (class Child-Pugh C)- Severe renal impairment requiring dialysis
* Previous history of tendinopathy associated with quinolones- Any symptoms that suggest that the patient's current illness is allergic rhinitis (e.g., repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
* Diagnosis of rapidly fatal illness with a life expectance of less than 6 months- Previously enrolled in this clinical study- Uncorrected hypokalaemia
Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning

This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders type 1 and 2) based on machine learning.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, 19-70 years old
* Diagnosis with Bipolar I disorder, Bipolar II disorder, Major depressive disorder based on DSM-5 criteria, in euthymic state for more than two weeks at the time of the recruitment
* Android smartphone users, capable of installing and executing the CRM application
* Consent to wear wearable device (Fitbit) continuously and synchronize and backup data regularly

Exclusion Criteria:

* Patients who have not experienced major depressive, manic, or hypomanic episode in the last two years
* Patients who are difficult to specify mood episode or evaluate symptoms of mood episode independently due to personality traits (borderline personality trait, cyclothymic temperament, etc.)
* Patients with degenerative neurological disorders (Parkinson's disease, dementia, Huntington's disease, etc.), neurodevelopmental disorders (intellectual disorder, autism spectrum disorder, down syndrome, etc.), epilepsy, severe traumatic brain damage, stroke, and other brain neurological disorders
* Inmates or patients who are forced into custody for the treatment of mental or physical illness (non-voluntary isolation or hospitalization)
* Patients with difficulties in understanding the objectives and process of the study and the potential benefits and risks of participating in the study
Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention

The aim of this study is to determine whether postprandial hyperglycaemia plays an important role in oxidative stress phenomena and influences their harmful effects on the arterial wall.

25 type 1 diabetic patients practicing FIT and with an HbA1c value of 8 percent or less at the beginning of the study will be recruited. The 25 control subjects will be recruited after the patients, so that they can be paired by age and sex.

Patients will be randomized via an alternative cross over study design for 2 periods of 3 months, i.e. preprandial or postprandial injection of an ultra fast acting analog. During the 6 months of the study, slow acting analog doses will be adjusted on the basis of basal glycaemia values. The fast acting analog doses will be adjusted on the basis of an optimized algorithm available on each patient's PDA phone electronic diary.

Blood and urine samples will be collected at M0, M3 and M6 to evaluate the stress oxidant grade and its consequence on atherogenesis:

Oxidative Stress evaluation: plasma parameters (lipid peroxide derivatives, semicarbazide sensitive oxidase amine activity), erythrocyte and leukocyte cell parameters (reduced and oxidised glutathion, dismutase superoxide activity (SOD) Cu and Mn dependent, glutathion peroxidase, and catalase), urinary parameters (isoprostane F2) Evaluation of consequences of oxidative stress on atherogenesis processes: inflammatory parameters (CRP, TNFa, IL 6), adhesion molecules (VCAM 1, ICAM 1, P selectine), adipokines (leptine, resistine, adiponectine), coagulation factors (PAI 1), platelet and endothelial microparticles, The pre and postprandial glycaemic stability of each patient will be monitored using PDA phone systems, and HbA1c will be measured at M0, M3 and M6.

Expected results and outcomes:

It is important to know if, in patients with comparable glycaemic stability, these two insulin treatment regimens are associated with significant differences in oxidative stress and anti oxidant defenses.

These results may help us to define a postprandial insulin treatment regimen (which is more flexible as regards meals) or a preprandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* treaties by basal / bolus with a ultra rapid analogue or a pump with a ultra rapid analogue
* Adults between 18 and 50 years old
* Patients practicing FIT
* Written informed consent obtained prior to enrollment in the study
* HbA1c ≤ 8%

Exclusion Criteria:

* Diabetes other than DT1
* Complications: coronary or peripheral arteriopathy
* Pathologies being able to interfere with the study: HTA, dyslipidemia, nicotinism, inflammatory , cancerous pathology...
* Psychiatric pathologies incompatible with the study
* Pregnancy
Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

This study aims to study the correlation between biomarkers of myocardial fibrosis (extracellular volume fraction calculated by cardiac magnetic resonance imaging (MRI) (T1-mapping) and levels of molecular biomarkers of fibrosis) and adverse events in a population of patients with repaired tetralogy of Fallot.

The main causes of mortality in adults with repaired tetralogy of Fallot (TF) are sudden death and heart failure. Myocardial fibrosis has been linked to the appearance of arrhythmias and ventricular dysfunction in other patient populations, but this association is poorly studied in patients with TF, perhaps because research in congenital heart disease (CHD) requires multicenter studies, difficult to carry out. Interstitial myocardial fibrosis assessed by molecular and imaging biomarkers is associated with adverse events in patients with repaired Fallot tetralogy.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with repaired tetralogy of Fallot or double outlet right ventricle Fallot type

Exclusion Criteria:

* Patients with pathologies that may interfere with the determination of the extracellular volume of myocardium (ischemic heart disease, storage diseases).
* Patients with pathologies that affect collagen metabolism (liver cirrhosis, stage ≥4 renal insufficiency, pulmonary fibrosis, metabolic bone disease, connective tissue diseases, active neoplasms, active treatment with corticosteroids and bone fractures or surgery in the previous 6 months).
* Pregnancy.
* Denial of informed consent.
* Patients with claustrophobia and pacemakers or defibrillators.
Effect of N-acetylcysteine on Renal Functioning of Chronic Kidney Diseases(CKD) Patients After General Anesthesia

Acute kidney injury (AKI) is one of the most serious and frequent complication of general anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD patients often need some surgical interventions that have been done under general anesthesia; they therefore have an increased probability to develop AKI.

N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties, reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney from injury induced by contrast media, ischemia, and toxins.

Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in renal functioning in CKD patients undergoing major surgery under general anesthesia.

Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40) patients that should undergo surgical interventions under general anesthesia and will divide to 3 groups as follows: group 1- about 40 patients which should undergo major vascular surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B). Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery. Subgroup B will receive placebo (saline).

Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after surgery in all patients. An additional blood samples for assessment of nitric oxide and cytokine levels will be taken from each patient before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia

Exclusion Criteria:

* pregnancy
* single kidney
* heart failure (NYHA class III-IV)
* hepatic failure
* mental diseases