cyrilzakka/clinical-trials huggingface dataset:
Effect of OMEGA3 Supplementation in Diabetic Retinopathy

The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.

Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public health problem.

In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while diabetic macular edema (DME) affects 5% of them.

Currently, apart from the balance of diabetes and other cardiovascular risk factors, no specific treatment is given for the minimal and moderate non-proliferative forms.

* DHA concentration in the retina can be modified according to the patient's diet.
* Minimal diabetic retinopathy does not currently benefit from specific treatment outside of diabetic control.
* Omega 3 are already known for their beneficial effects on the retina, brain and cardiovascular system but their effectiveness has not been tested on diabetic retinopathy.
* It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy.

A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet, improved the stage of DR in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* For women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study.
* Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification.
* AV \> 6/10
* One eye included. If both are affected, the eye with the poorer perfusion should be included.
* Affiliated to a social security scheme

Exclusion Criteria:

* \< 18 years old.
* Pregnant or breastfeeding woman
* Other retinal pathologies that may interfere with the results (Patients previously treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness \> 280 µm, Eyes with spherical equivalent greater than 8 Diopters, OCTA images not interpretable with many artifacts.)
* Hypersensitivity to any of the components of Nutrof or Meralut
* Taking the antivitamin k
* Known deficit in G6PD-
* History of renal lithiasis
* Kidney failure
* Immunosuppression
* Chronic Ethylism
* History of hepatopathy
* Intracranial tumor, intracranial hypertension
* Refusal to participate
* Patient participating in an intervention study.
Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis

The investigators aim to compare the standard bulb aspirator with that of a nasal oral aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of oral intake, respiratory relief, parental device preference and adverse events.

This study will be a single center, single blind, randomized controlled trial in the pediatric emergency department (ED) at Dell Children's Medical Center of Central Texas (DCMC). An ED discharge diagnosis of bronchiolitis will trigger patients to be randomized to receive a bulb aspirator or nasal oral aspirator for home secretion management use. Prior to dispensing the randomized aspirator, a pre-distribution questionnaire will be administered. Additionally, patients will receive a diary to complete for 3 days post ED discharge. Research personnel will call families on day 4 as a reminder to return the diary and again on day 14 to obtain a verbal post-study questionnaire. Research personnel will perform chart review on all patients looking for unscheduled patient return visits for bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* Children \>28 days of life to \< 2 years of age discharged home from the DCMC ED with a diagnosis of bronchiolitis (diagnosis made per provider discretion)
* Caregiver fluent in English or Spanish

Exclusion Criteria:

* Previous enrollment
* Hospital admission
* Parental refusal to be randomized to an aspirator device (i.e., family prefers current device and does not wish to be randomized to a potentially different product)
* Current bacterial pneumonia
* Diagnosis of asthma
* Chronic lung disease
* Significant underlying cardiac disease
* Chronic neuromuscular disease
Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease

Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease.

Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver T cell infiltrates.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol excess intake and suspected liver disease
* Alcohol excess intake and clinical liver cirrhosis
* chronic hepatitis C virus infection and suspected liver disease
* chronic hepatitis C virus infection and clinical liver cirrhosis

Exclusion Criteria:

* bacterial or fungal infection
* immunosuppressive treatment
* other causes of liver disease
FearLess in Cognitively Intact Patients With Glioma

This study will assess the preliminary feasibility and acceptability of FearLess, a newly-developed psychological intervention for fear of cancer recurrence (FCR) among cognitively-intact patients with glioma.


Eligibility Criteria:
Inclusion Criteria:

Patient inclusion:

* Confirmed glioma diagnosis (grade II-IV) via histopathology
* Be a minimum of 2 weeks post surgical repair or biopsy (if applicable)
* Elevated FCR \[\> 13 on Fear of Cancer Recurrence Inventory\]
* Primarily English speaking

Caregiver Inclusion:

* Loved one, or non-paid care partner to a patient with a confirmed glioma diagnosis (grade II-IV) via histopathology
* Elevated FCR \[\> 13 on Fear of Cancer Recurrence Inventory\]
* Primarily English speaking
* Age 18+

Exclusion Criteria:

Patient:

* Cognitive impairment \[\< or equal to 31 on the Telephone Interview for Cognitive Status (TICS)\]
* Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
* Inability to understand and provide informed consent.

Caregiver:

* Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
* Inability to understand and provide informed consent.
Women At Risk: The High Risk Breast Cancer Program

The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.

This is a longitudinal cohort study that collects data of eligible women at risk for developing breast cancer. Patient information will be entered into a secured computerized database that is used for research on the prevention, early detection and treatment of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* one or more first-degree relatives (mother, daughter, or sister) with pre-menopausal breast cancer
* two or more first-degree relatives with post-menopausal breast cancer
* tested positive for a BRCA1 or BRCA2 mutation
* a history of biopsy-proven atypical ductal hyperplasia or atypical lobular hyperplasia
* a history of biopsy-proven lobular neoplasia (lobular carcinoma in situ)

Exclusion Criteria:

* DCIS (ductal carcinoma in situ)
* previous diagnosis of breast cancer
Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

observational epidemiological study of patients affected by systemic amyloidosis


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with amyloidosis or asymptomatic carriers of mutations in the transthyretin gene
* minimum age of 18 years at the time of diagnosis
* obtaining informed consent

Exclusion Criteria:

* nothing
ML Decision Model for G-NEC Adjuvant Therapy

Gastric neuroendocrine carcinoma (G-NEC) is a rare and aggressive tumor originating from neuroendocrine cells in the stomach lining. It is characterized by a high propensity for recurrence and a generally poor prognosis. Due to its rarity, there is limited data and no established consensus on the optimal postoperative adjuvant therapy, making treatment decisions challenging for healthcare providers.

This study is a retrospective analysis focusing on evaluating survival rates, identifying prognostic factors, and formulating treatment recommendations for patients with G-NEC. By analyzing real-world clinical data, we aim to better understand the factors that influence patient outcomes and to develop evidence-based strategies for improving survival. Our goal is to provide clinicians with valuable insights and tools to make more informed treatment decisions, ultimately enhancing the quality of care and outcomes for patients with this challenging disease.


Eligibility Criteria:
Inclusion Criteria:

* (1) patients who underwent radical surgery without any neoadjuvant therapy;
* (2) pathology confirmed NEC or mixed adenoneuroendocrine carcinoma (MANEC).

Exclusion Criteria:

* (1) history of other malignant neoplasms;
* (2) treatment with endoscopic submucosal dissection or endoscopic mucosal resection or thoracotomy;
* (3) incomplete clinical data (including pathological, adjuvant chemotherapy, and follow-up information);
* (4) receipt of alternative adjuvant treatment regimens;
* (5) death within 30 days postoperatively.
Comparison Study on Hair Apposition Technique Performed Between Nurses and Doctors in Emergency Department.

The purpose of this study is to compare the effectiveness, complications and benefits of Hair Apposition Technique(HAT)performed by nurses or doctors.

Hair Apposition Technique (HAT) is a relatively new technique for treating certain scalp lacerations. It has been shown to be equally acceptable as compared to the standard toilet and suture. This procedure has been the technique of choice for suitable scalp lacerations in Department of Emergency Medicine, Singapore General Hospital (DEM, SGH) and Emergency Medicine Department, National University Hospital (EMD, NUH).

Currently HAT is being performed by doctors in the respective hospitals. Nurses, on the other hand, are routinely using tissue adhesives for minor wound closure. However, nurses in Kandang Kerbau Women and Children Hospital (KKWCH) have been routinely using HAT for 1 year now. Studies had been also been done by nurses in treating of minor wounds using various tissue adhesives as well as hair knotting technique.The trend of nurses handling minor wounds with tissue adhesives, hair knotting technique as well as HAT suggested the possibility of nurses performing HAT to a degree as competent as a doctor.

This study aims to compare the effectiveness, complications and benefits HAT performed between nurses and doctors in the Emergency Department.

Eligibility Criteria:
Inclusion Criteria:

* All age group
* Linear lacerations of scalp
* Lacerations less than 10cm in length
* Hair at least 3cm in length

Exclusion Criteria:

* Severely contaminated wounds
* Actively bleeding wounds
* Patients with unstable vital signs or altered mental state
Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy

This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures.


Eligibility Criteria:
Inclusion Criteria:

- All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.

Exclusion Criteria:

* Admission core body temperature \<35°C.
* Known contraindications to hypothermia, including hemodynamically unstable patients, new/symptomatic arrhythmia, hematological dyscrasias that affect thrombosis (cryoglobulinemia, sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thrombo-angiitis obliterans.
* Skin lesions not allowing secure application of the cooling cap.
* Unable to participate in follow-up at 3 months (e.g., resides outside of Alberta).
Stem Cell Applications in Biliary Atresia Patients

Recently, mesenchymal stem cell (MSC) transplantation has emerged as a promising treatment for liver cirrhosis in adults. Additionally, bone marrow-derived stem cell transplantation has shown success in treating children with biliary atresia (BA). This study aims to evaluate the efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy in BA through a multicentric randomized controlled trial.

Biliary atresia (BA) is the most common cause of chronic cholestasis in neonates and accounts for at least 50% of pediatric liver transplants. The incidence of BA is estimated to range from 1:5000 to 1:19000 live births. If the operation is not performed, all patients will die due to complications of liver cirrhosis. Recently, mesenchymal stem cell (MSC) transplantation has been found to be a promising treatment for liver cirrhosis in adults. Stem cell transplantation derived from bone marrow has also been successfully applied to children with BA. The aim of this study is to demonstrate the efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy in BA by planning a multicentric randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Infants were diagnosed with liver cirrhosis due to biliary atresia following Kasai's operation.
* The patients two months old or older and exhibited signs of cirrhosis after the procedure, including hepatomegaly, congestive splenomegaly, elevated liver enzymes, esophageal varices (confirmed by endoscopy), and cirrhosis (confirmed by liver biopsy).

Exclusion Criteria:

* Epilepsy
* Neurological disorders
* Coagulation disorders
* Diabetes
* Syndromic type biliary atresia
* Allergies to anesthetic agents
* Severe health conditions such as cancer or failure of the heart, lungs, liver, or kidneys, active infections, and severe psychiatric disorders.
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.

Exclusion Criteria:

* Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR \> 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.
Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin N with Humulin® N in healthy subjects.

The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 17 to 43 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration).

Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and post-menopausal female subjects. Post-menopausal defined as 12 months of no menses without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (\>= 25.8 IU/L).
2. Age between 18 and 55 years, both inclusive
3. Body mass index between 18.5 and 29.0 kg/m\^2, both inclusive.
4. Fasting plasma glucose concentration \<= 100 mg/dl.
5. Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.

Exclusion Criteria:

1. Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
2. Systolic blood pressure \< 95 mmHg or \>140 mmHg and/or diastolic blood pressure \< 50 mm Hg or \>90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
3. Pulse rate at rest outside the range of 50-90 beats per minute.
4. Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.

As secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA.

This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Patient ⩾ 18 years;
* Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;
* Affiliated to a social security scheme;
* Have signed the written informed consent form.

Healthy control subjects:

* Adult women and men;
* Subjet free of chronic pathology;
* Affiliated to a social security scheme;
* Have signed the written informed consent form.

Exclusion Criteria:

Patients:

* Patients unable to understand the proposed study and/or sign a informed consent form;
* Pregnant women or breast feeding women;
* Patient ⩾ 18 years;
* Patients under guardianship or curatorship;
* Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;
* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
* Foreign patients under french AME scheme;
* Patients had have participated in the prior study Microbiart.

Healthy control subjects:

* Subjects unable to understand the proposed study and/or sign a informed consent form;
* Pregnant women or breast feeding women;
* Subjects \< 18 years;
* Subjects under guardianship or curatorship;
* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
* Refusal of subjects to participate to the study;
* Foreign patients under french AME scheme;
* Subjects had have participated in the prior study Microbiart.
GROUP FOR TRALI STUDY. SEMICYUC.

OBJETIVES:

1. To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.
2. To determine the incidence of transfusion-related acute lung injury (TRALI) in critically ill patients.
3. To research the morbi-mortality of TRALI.

Actually there are no published European data on the incidence of acute lung injury by transfusion (TRALI) in critically ill patients, in Europe, estimates of TRALI incidence are limited to passive reports of national blood banks. This multicenter study of Spanish ICUs will investigate the incidence and TRALI predisposing factors (associated with the patient, the transfused blood product and the presence or absence of mechanical ventilation).

Design:

Prospective multicenter observational study.

Patients:

All patients transfused in eleven spanish intensive care units (UCI) from October 1, until November 30, 2010. Patients with less of 18 years old, or transfused six hours before be included in this study or seriousness patients with a length of stay \<24 hrs will be excluded.

Variables:

* Patient data collection: Demografic data (age, gender), Clinical data (comorbid conditions), Admission diagnostic , Complications during the stay and severity of illness scores: Acute Physiology and Chronic Health Evaluation (APACHE II) score, Sequential Organ Failure Assessment (SOFA) score, Euroscore.
* Transfusion factors: Type of blood product, time of infusion and volumen transfused, storage age and donor sex.
* Respiratory factors: Main ventilation and oxigenation parameters and type of respiratory support before and after transfusion.

For each transfusion episode was completed two data tables (see last page of the booklet of data collection):

* Before the transfusion (baseline) are listed the values of the patient's respiratory function, the analytical value that is transfused (Hb, INR, APTT, PT, platelets) and the number of the bag that is transfused (to apply blood bank storage time and sex of the donor).
* After the transfusion are recorded the volume and time infusion and 6 hours after transfusion are collected again the parameters of the patient's respiratory function and radiographic changes.

According to official criteria shall be noted if the patient has exhibited a classic TRALI, possible TRALI, or a worsening of their respiratory function after transfusion.

Eligibility Criteria:
Inclusion Criteria:

* All patients transfused in eleven spanish intensive care units (UCI) from October 1, until November 30, 2010.

Exclusion Criteria:

* Patients with less of 18 years old, or transfused six hours before be included in this study or seriousness patients with a length of stay \<24 hrs will be excluded.