cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye

The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome

To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry eye syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Man/woman ≥ 18 years old, able to freely give consent to participate in the study
* At least 1 of the following tests altered:

  * Ocular Surface Disease Index (OSDI) Test symptoms \> 32
  * BUT ≤5 seconds
  * Oxford staining ≥ 3
  * Schirmer Test without anesthesia ≤ 5 mm

Exclusion Criteria:

* Sensitivity or known intolerance to any of the products used in the study
* Contraindication of venipuncture
* Story of ocular infections within the 6 previous months to study inclusion
* Any active ocular pathology other than Dry Eye Syndrome
* Use of contact lenses in the 3 previous months to study inclusion
* No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.
* Participation in another clinical trial in the last 30 days before study inclusion
Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database

Atrial fibrillation is the most prevalent sustained arrhythmia worldwide with a great morbimortality. Some populations are more at risk to develop atrial fibrillation like patients suffering from inflammatory diseases or patients suffering from cancers. This is at least explained by the inflammatory environment related to these both conditions. Many experimental studies and clinical studies support the role of inflammation and immunity in atrial fibrillation genesis by modulating atrial action potential et by promoting fibrosis.

Immunomodulators are drugs used to stimulate or inhibit the immune system for two main indications : cancers and immune disorder diseases which both promote atrial fibrillation. Due to their interactions with inflammation and immunity, immunomodulatores may further promote the risk of atrial fibrillation, particularly in a population already at risk.

Based on the World Health Organization global database, the main objective of this study is to investigate the association between immunomodulators and the occurrence of atrial fibrillation reported in the database.

A disproportionality analysis will be performed. It will aim to assess whether immunomodulators are associated with a greater risk of atrial fibrillation.

Secondary objectives aim to describe the cases of atrial fibrillation among immunomodulators associated with atrial fibrillation in the main analysis, to describe coprescription among immunomodulators associated with atrial fibrillation in the main analysis, to analyse the role of immunomoduloators medical indication in the overrisk of atrial fibrillation, and to try to highlight some immune mechanisms promoting atrial fibrillation regarding the immunomodulators associated with atrial fibrillation in the main analysis.


Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/09/2022
* Patients treated with FDA approved immunomodulators (approval the 1st January 2023).
CRRT for Glutamate Elimination After Cardiac Arrest

Glutamate is known to be a mediator for apoptosis after brain hypoxia e.g. due to cardiac arrest. This pilot trial evaluates the possibility of elimination of Glutamate by CRRT after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* post cardiac arrest

Exclusion Criteria:

* hemodynamic instable
* in-hospital cardiac arrest
A Father-friendly Neonatal Intensive Care Unit

An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

The study was conducted in 3 steps

1. A baseline measurement
2. Development and implementation of the intervention a father friendly NICU
3. After measurement

Different questionnaires were used:

* The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
* The Nurse Parent Support Tool (NPST)
* A questionnaire intended to measure nurses self-efficacy (SE).

The study was approved by the Danish Data Protection Agency (No 19/20297) and the procedures were in accordance with the Helsinki Declaration. In accordance with the Danish law, this study did not need to be reviewed by an ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* fathers/mothers with infants admitted to the NICU were eligible
* nurses who work in Danish NICUs

Exclusion Criteria:

* fathers/mothers who did not understand verbal and written Danish
* fathers/mothers of critically ill newborn infants
* fathers of newborn infants whose mother was critically ill
* fathers/mothers of newborn infants admitted to the NICU from home.
* nurses without patient-contact, on maternity- or long-term sickness-leave
A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms

The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.

Eligibility Criteria:
Inclusion Criteria:

* Patients not currently being treated with antipsychotic medication and neuroleptic naive patients
* Diagnosis of schizophrenia or schizoaffective disorder
* Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

Exclusion Criteria:

* Patients at immediate risk of committing harm to self or others
* Treatment with clozapine within 3 months prior to baseline
* History of neuroleptic treatment
* Current antipsychotic treatment
Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)

The study is randomized and it will be conducted in the field of routine clinical practice. A total of 100 consecutive patients planned to receive radiotherapy for prostate cancer will be enrolled.

The patients will enter the study as controls (50 patients that won't receive any experimental IMP) or as treated-group (50 patients that will be also treated with the experimental IMPs, Ialuril® and Ialuril® Soft Gels) according to a predefined, centre-specific randomization.

Radiotherapy will last for 6 weeks. During planning of treatment, regimen and average dose to the whole bladder will be recorded to assess the impact of EBRT on urinary symptoms.

The treated-group will receive also intravesical Ialuril® weekly for 6 weeks (in the 24 hours before every radiation therapy weekly schedule), plus oral treatment with Ialuril® Soft Gels capsules (1 capsule twice a day after meals, at a distance of 12 hours, for 12 weeks).

The control-group will receive radiotherapy only for 6 weeks.

The Primary Objective is to assess the tolerability and safety of HA-CS intravesical instillations (Ialuril®) plus an oral combination of curcumin, quercetin, HA and CS (Ialuril® Soft Gels) in male patients undergoing radiotherapy for prostate cancer The efficacy of the treatment will be evaluated at the end of the study once received all the crfs.

Eligibility Criteria:
Inclusion Criteria:

* Male patients planned to receive primary radiotherapy for prostate cancer.

Exclusion Criteria:

* Female patients
* Patients with a life expectancy of less than 24 months
* with radiological confirmed metastasis
* with documented urethral strictures
* undergoing chemotherapy
* who received brachytherapy
* who received chemo-radiotherapy for prostate cancer in the past
* previously treated with Bacillus Calmette-Guerin (BCG)
* with post-void residual (PVR) \> 200ml
* with clinical evidence of bladder calculi
* with neurogenic bladder or neurologic disease at risk for neurogenic bladder
* suffering from any lower urinary infections (UTIs, tuberculosis)
* with unstable cardiovascular disease
* with Congestive Heart Failure (CHF)
* with current nitrate use
* with current anticoagulants use (i.e. warfarin, heparin, etc.)
* with clinically significant hepatobiliary or renal disease
* with history of significant CNS injuries within 6 months
* with any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Coaching of Diabetic Patients After Hospital Discharge

One third of the costs of medical care for people with diabetes are related to hospitalization." Difficult" diabetic patient, i.e. those with very high HbA1c, patients \> 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an initial hospitalization related to diabetes or its complications. The objective of the study is to test if a coaching with a care coordinating team after hospital discharge would decrease diabetes-related rehospitalization rate compared with usual care.

Patients with type 1 (T1D) or type 2 diabetes (T2D) hospitalized (\>24h) and presenting at least a risk factor for readmission after discharge at home, will be randomized, at time of discharge, between 2 groups: an "intervention" group and a control group (usual management). Intervention will consist in optimized organization of discharge at home followed by a ambulatory individualized coaching by a nurse including an initial situation assessment, a consultation meeting with the patient's GP in order to propose a Health Personalized Plan, then a follow up program with a face to face session each trimester in order to remind the objectives, to assess compliance to the plan, to evaluate difficulties encountered and to help to find solutions. Final data collection will be done in both groups by questioning the patient's general practitioner (GP) and by collecting data on potential hospitalization. Expected duration : 3 years. Readmission rate, duration and causes of hospitalization will be compared between both groups. Impact of the results : Reduction of costs, improved use of hospital specialized resources.

Eligibility Criteria:
Inclusion Criteria:

* type 1 or type 2 diabetes AND AT LEAST ONE of the following criteria:

  * admission for more than 5 days
  * unplanned admission
  * at least one urgent care/emergency room visit in the 6 previous months, whatever its cause
  * HbA1c \> 10% on admission
  * cardiovascular event in the previous year : cardiac failure, myocardial infarction, coronary or peripheral revascularization procedure, stage IV peripheral arteriopathy, stroke.
  * occurence during the previous year of a foot lesion requiring an admission or lasting more than one month (foot lesion risk stage 3)

Exclusion Criteria:

* patients with one of the following co-morbidity: cancer in active phase of treatment, Parkinson's disease treated, severe chronic respiratory failure,
* refusal of signing the consent,
* patients non affiliated to Social Security,
* pregnant women,
* people who do not understand French (except if accompanied by somebody able to translate),
* renal dialysis,
* patients aged less than 18 years,
* patients already in a similar type of trial
* the arisen of a pregnancy or a cancer will cause the stop of the study
Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

The purpose of this study is to verify the efficacy of Rostafuroxin in the treatment of essential hypertension and to determine the best effective dose to be administered in the general hypertensive population and in a subset of this population in which genetic patterns could be involved in the etiology of essential hypertension.

Elevated arterial pressure is probably the most important public health problem. about 30% of the world adult population are affected by hypertension in industrialised countries. Development of a pharmacogenomic approach to the therapy of primary hypertension give new opportunities for the treatment of hypertension. This approach consists in the identification of the genetic-molecular mechanisms responsible for hypertension in a given subset of patients, and in the development of drugs able to interfere with such mechanisms, thus leading to very selective therapeutic interventions with enhanced efficacy and reduced side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with grade 1 or 2 of essential hypertension
* Less than 3 risk factors (age \> 55 if male, smoking, dyslipidemia, family history of CV disease occurring before 55 years in men and 65 in women
* Naive patients or currently on monotherapy or one combination tablet
* SBP between 140 and 169 mmHg

Exclusion Criteria:

* Atrial fibrillation or left or right VBBB
* Left ventricular hypertrophy
* Significant renal or hepatic disease
* Obesity \> 30kg/m2
* Diabetes mellitus
Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

This proposed study will assess the hemodynamic effects and measure the systemic absorption of topically applied oxymetazoline in patients undergoing functional endoscopic sinus surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline as standard of care during the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are scheduled for:

  1. Functional endoscopic sinus surgery
  2. Turbinate reduction (with or without tonsillectomy and/or adenoidectomy)
  3. Adenoidectomy

Exclusion Criteria:

* Been treated with oral decongestants or antihistamines within 24 hours of surgery
* Are taking anticoagulants
* Have a history of nasal trauma
* Have a history of epistaxis
* Have a history of hypertension or cardiac disease
* Allergy to oxymetazoline
Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects

The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.

Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese or Caucasian subjects between 20-65 years of age (included)
* Subjects must have a body mass index between 18-28 kg/m² (included)
* Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile

Exclusion Criteria:

* A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug
* Concurrent participation or participation within 3 months prior to the initial study drug administration in a drug/device or biologic investigational research study
* A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
* Subject expresses current desire to have (more) children
* Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding
Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial

Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a long-term programme of medical evaluation, exercise, education and counseling. National guidelines have recognized the positive impact that attendance at CR can have following heart attacks, angina and other heart problems. Patients who attend such a programme have been shown to have reduced health problems. Despite this, research suggests that the use of these services is poor and that the majority of patients eligible for these programmes do not continue to attend after their first class. A range of factors have been associated with non-adherence to CR, including psychological factors such as people's beliefs about their illness. For example, patients with high levels of perceived control over their illness after a heart attack appear to be more likely to attend CR classes than those with low levels of perceived control. Such findings suggest that changing patients' illness beliefs, specifically those associated with illness control and illness consequences, could help to increase adherence to CR programmes. Increased adherence to CR could improve health outcomes for patients with cardiac illnesses. The present study is therefore investigating the effectiveness of a one-session psychological intervention, based on a theory called the Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac rehabilitation. Participants will be randomly assigned to a treatment or a non-treatment group. It is hoped that those who receive the treatment session will attend more CR classes.


Eligibility Criteria:
Inclusion Criteria:

* Attending first cardiac rehabilitation class at one of three hospital sites
* Participants had to be over 18

Exclusion Criteria:

* Unable to read and understand English information sheet and consent form
Total Lifestyle Coaching Pilot Study (TLC)

The investigators aim to develop, pilot and evaluate a new "Total Lifestyle Coaching" (TLC) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (BMI) exceeds 25.

This is a single-arm pilot study of patients at the Revere Healthcare Center with a BMI greater than 25. The intervention consists of a single in-person assessment with a dietician followed by telephone coaching sessions addressing nutrition, sleep, stress-reduction skills, and physical activity over the course of 6 months. Study team assessed anthropomorphic, demographic, and behavioral measures prior to the initial dietician assessment and at study completion (6 months following enrollment). Semi-structured exit interviews assessing participants' experiences in the program were also conducted following program completion.

Eligibility Criteria:
Inclusion Criteria:

1. age 21 and older
2. body mass index (BMI) exceeds 25
3. speaks English
4. has access to a telephone
5. able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period.
6. overweight (BMI exceeds 25)
Comparision of Different Dose of Neostigmine at Advanced Decurarization

Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years
* informed consent signed
* Patient undergoing any type of scheduled surgery under general anesthesia for which curarization with eventually a maintenance is indicated
* ASA score between I to III

Exclusion Criteria:

* patient \> 75 years and \< 18 years
* body mass index \> 32 mg/m²
* neurology disease, neuromuscular or muscular disease
* peripheral neuropathy
* coronary heart disease
* asthma
* familial history of malign hyperthermia
* difficulty of intubation and ventilation
* full stomach
* known or suspected allergy to one of the study drug
* mecanique obstruction of digestive or urinary tract
* open-angle glaucoma
* patient with risk of urinary retention linked to urethra-prostatic disorder
* concomittant medication with a influence known on neuromuscular (aminosid, anti-convulsif and corticosteroid
* child bearing women or nursing mother
* no affiliation at a social security