cyrilzakka/clinical-trials huggingface dataset:
Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

The purpose of this study is to test a novel and tolerable office-based treatment method, sclerotherapy with sodium tetradecyl sulfate, for recurrent epistaxis (nosebleeds) related to Hereditary Hemorrhagic Telangiectasia (HHT) disease.

Ninety percent of patients who suffer from Hereditary Hemorrhagic Telangiectasia (HHT) experience epistaxis which can range from mild to recurrent, severe, life threatening episodes. Current methods to treat significant epistaxis have limitations, namely the need for general anesthesia and repeated treatments. The objective of this study is to test a novel and tolerable office-based treatment method, sclerotherapy with sodium tetradecyl sulfate (STS), for recurrent epistaxis related to HHT.

Sclerotherapy is the treatment of vascular lesions by injection with an agent which causes thickening of the vessel wall, obstruction of blood flow, clot formation and collapse of the lesion. Sclerotherapy is an established treatment modality for vascular malformations in the skin, GI tract, genitourinary tract and has been used for lesions in various sites in the head and neck. STS is an anion surfactant (detergent) that is commonly used for sclerotherapy. There are case reports in the literature describing sclerotherapy treatments for epistaxis related to HHT using other agents, but these case reports did not lead to prospective studies. We have performed a pilot study to analyze the tolerability and effectiveness of sclerotherapy with STS in a series of patients with recurrent epistaxis related to HHT. In our series, the treatment was found to be well tolerated and effective, based on patient administered questionnaire and review of clinical data. No complications related to the procedure were noted. Further prospective studies would help elucidate the role of sclerotherapy with STS in the treatment algorithm for recurrent epistaxis related to HHT.

Our goal is to conduct a prospective, randomized-controlled trial to test the efficacy and tolerability of sclerotherapy using STS in the treatment of recurrent epistaxis due to HHT. A modified crossover design will be utilized with the intervention group receiving sclerotherapy, plus any additional, previously utilized standard treatment methods needed to control epistaxis. The control group will receive their current standard treatment methods, followed by delayed intervention with sclerotherapy. The primary outcomes will be frequency and severity of epistaxis. Secondary endpoints will be hemoglobin level, tolerability of treatment, additional treatment requirements, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of HHT based on the Curacoa Criteria
* age 18 and older
* cognitive ability and willingness to sign the study consent form and complete the study forms and questionnaires

Exclusion Criteria:

* previous sclerotherapy with Sodium Tetradecyl Sulfate
Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission

With this investigation, researchers wil look for a link between the appearance of anorexia nervosa and autism spectrum disorders in minors. Previous studies made clear already that patients with anorexia nervosa show elevated characteristics of autism spectrum disorder, when being meassured in adults and in patients in the acute fase of their anorexia nervosa. The purpose of this invenstigation is to see if their is also an elevated incidence of characteristics of autism spectrum disorder in minors with anorexia nervosa in remission.

34 patients who are still minors and were previously treated in the Child and Adolescent Psychiatry Department (PAika) of the University Hospital in Brussels, will be contacted to ask if they would volunteer in this investigation. If the minors and their parents give their permission, they will be asked to fill in multiple questionnaires, measuring the current symptoms of anorexia nervosa, characteristics of autism spectrum disorder and global functioning of the minors. The questionnaires will be send and returned by post.

Eligibility Criteria:
Inclusion Criteria:

* Patients speaking Dutch
* Previously treated in UZ Brussel for anorexia nervosa
* Informed consent signed by children and parent(s)

Exclusion Criteria:

* Patients and/or parents don't speak Dutch
* Adults
* No informed consent obtained
Health Status of Workers in Photocopier Units

Photocopiers are indispensable in today's working environment. However, photocopiers emit a number of harmful chemicals during their operation. Photocopier toners also contain a number of potentially toxic substances. Chronic exposure to these substances may compromise the health of photocopier operators. This study is aimed to understand if chronic exposure to photocopier emissions is harmful to human health.


Eligibility Criteria:
Inclusion Criteria:

Exposure to photocopier emissions for minimum 2 years professionally

Exclusion Criteria:

Any clinical abnormality
Nursing Care Interventions According to Integrative Nursing and Omaha System in Elderly Women Feeling Loneliness

Objectives: The present study investigates the effects of nursing care interventions on the physical, psychological, social and spiritual health of the elderly women with high level of loneliness according to the principles of integrative nursing and Omaha System.

Methods: This study protocol describes a randomised controlled trial with to parallel group design. After the level of loneliness of elderly women will be determined by the Loneliness Scale for the Elderly in the Family Health Center, women with high levels of loneliness will be randomly assigned to the intervention and control group. Nursing care interventions consisting of group-based (sightseeing, picnics, theater, cinema) and individual according to Integrative Nursing and Omaha System. Elderly women who feel loneliness will continue for 12 weeks. Pre-tests and post-tests will be completed during home visits made by the researchers.

Discussion: This study will provide evidence regarding the effectiveness of nursing care interventions that include the comprehensive (physical, psychological, social and spiritual) evaluation of their health, and contribute to provide care in terms of Integrative Nursing and Omaha System.


Eligibility Criteria:
Inclusion Criteria:

* to be independent according to the Katz Daily Activities Activity Scale;
* no problem in physical activity with the suggestion of the doctor in Family Health Center;
* living alone or with family;
* good cognitive state (place, time and person orientation) with the suggestion of the doctor; - the willingness to participate in the study

Exclusion Criteria:

* to live in any elderly care center or nursing home;
* to be semi-dependent and dependent according to the Katz Daily Activities Activity Scale
* to have a psychiatric disorder.
Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

This is a randomized control trial evaluating the efficacy of zanthoxylum nitidum tincture on preventing progression of paronychia caused by afatinib from grade 1 to grade 2/3. Enrolled participates will randomly receive original treatment or original treatment plus zanthoxylum nitidum tincture immersion of the sick nail(s).


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically or cytologically confirmed non-small cell lung cancer；
2. Undergoing treatment with afatinib；
3. With grade 1 paronychia；
4. Age between 18 to 80 years old；
5. Estimated life expectancy of more than months；
6. With the written informed consent.

Exclusion Criteria:

1. Paronychia before afatinib treatment;
2. Grade 2 or severer paronychia;
3. Stop using afatinib or with reduced dose of afatinib;
4. Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.
5. Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.
Molecular Signatures in Inflammatory Skin Disease

This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and disease control by integrating and modelling data across multiple cellular levels and time following specific blockade of single pathophysiological factors through use of licensed biologics during routine care as systems biology challenge. To this end, ultra-deep phenotyping and prospective molecular characterization in short time-intervals and different disease equilibrium states will be carried out in targeted small sets of patients. The different layers and types of clinical and molecular information will then be integrated (integrative personal omics profiling iPOP) for generating insights into disease pathways and for extraction of molecular signatures that correspond to clinical severity scores. It will provide a good starting point for planning future trials aimed at identifying biological patterns useful for guiding targeted treatment.

This is an exploratory study with the aim to identify molecular profiles and signatures in skin and blood that correlate with inflammatory skin disease, disease activity and disease progression, and that are associated with possible disease subtypes/endotypes. Primary target variables are differentially expressed genes (alone or in combination), secondary target variables are genetic, immunological and microbiological signatures. Influencing variables of interest include age of manifestation, disease duration, disease activity/severity, disease progression, comorbidities and therapy/treatment. Obtained biomaterial will be used for molecular profiling including DNA/RNA sequencing, ELISA, mass spectrometry, flow cytometry to identify markers and/or signatures that can correlate with individual disease courses.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with the protocol
* Diagnosis of chronic psoriasis or atopic dermatitis
* PASI score ≥ 10 or EASI score ≥ 16
* Investigator Global Assessment (IGA) ≥ 3
* Subject receives systemic therapy within routine care (in-label use of biologics)

Exclusion Criteria:

* Subject is unable to provide written informed consent or comply with the protocol.
* Having used immunosuppressive/immunomodulating therapy or phototherapy within 4 weeks before the baseline visit.
* Treatment of selected skin areas to be examined with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit.
Use of Pressure Garments for Burn Scars

1. Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy.
2. How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity.
3. Will Pressure Garment Therapy diminish discomfort due to pruritus.


Eligibility Criteria:
Inclusion Criteria:

* At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
* at least 1 year of age and no more than 17 years of age
* Wound closure
* No evidence of deep venous thrombosis or other vascular compromise.
* No concomitant conflicting study protocols.

Exclusion Criteria:

* Burn injuries not bilateral to upper and/or lower extremities.
* Evidence of vascular compromise.
* Conflicting protocols.
Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery

Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient.

With the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results.

Two main families of breast reconstruction techniques are often performed including advantages and complications impacting health related quality of life.

Routine assessment of health related quality of life in patients underwent breast reconstruction could allow to identify factors of satisfaction o be taken into account in the choice of breast reconstruction technique in order to improve practices and quality of life of patients


Eligibility Criteria:
Inclusion Criteria:

* Normal Breast Checkup ( Mammography, echography and breast magnetic resonance imaging)in the previous 6 months
* French speaking and writing fluency
* Agree to participate after receive all information

Exclusion Criteria:

* Patients with an inability to complete HRQOL questionnaires (cognitive disorders, language barrier)
* Patient with a failed first breast reconstruction
Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®

The specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment).

The main idea of the project was to address the study of some of the most important inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma... ) with the aim of identifying novel inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before entering the trial.
* Male and female 18-65 years of age.
* A clinical history of relevant rhinitis or rhinoconjunctivitis (with/without concurrent asthma) to grass pollen of at least one year prior to trial entry.
* Documented positive specific IgE against grass pollen (IgE ≥ Class 2) into the 5 previous years.
* Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Phleum pratense.
* Negative pregnancy test for childbearing potential females.
* Willing and able to comply with the trial protocol regimen.

Exclusion Criteria:

* Previous treatment by immunotherapy with grass allergen extracts.
* A clinical history of symptomatic perennial allergic rhinitis or asthma.
* Patients with contraindications for immunotherapy as established by the IT subcommittee of the EAACI or in the Summary of Products Characteristics of GRAZAX®.
* Positive pregnancy test (in fertile females).
* Being immediate family of the investigator or trial staff.
* A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
* Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
* Use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.
Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke

The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.

The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.


Eligibility Criteria:
Inclusion Criteria:

* Patients (or their person of trust in cases of inability) who have been informed about the research and given their consent to take part
* Patients aged 18 years or older
* Patients who have suffered a de novo recent ischemic stroke \< 12 hours
* Patients who had cerebral imaging (CT-Scan or MRI)
* Ischemic stroke severity, measured by the National Institute of Health Stroke Score (NIHSS), between 4 and 20

Exclusion Criteria:

Patients without national health insurance cover

* Patients with a clinical history of stroke
* Patients with cerebral or sub-arachnoid haemorrhage
* Patients with a transient ischemic attack
* Time of symptom onset unknown
* Patients with severe aphasia at the time of the ischemic stroke defined by a sub-score for item 9 (best language) of the NIHSS ≥ 2
* Patients with dementia prior to the ischemic stroke
* Patients with a significant loss of autonomy prior to the ischemic stroke, defined by a Rankin score ≥ 4
* Patients with aphasia before the ischemic stroke
* Patients with a contra-indication for cerebral MRI
* Pregnant or breast-feeding women
* Adults under guardianship
* Subjects in custody
* Patients who do not speak French
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men

Socially disadvantaged Black men are at increased risk for unhealthy drinking habits that may, in turn, increase preventable chronic disease. This project seeks to test the effectiveness of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) intervention for use within barbershop settings to reduce average drinking days and the number of unhealthy drinking days. Data from this study will further our understanding of how to reduce the risk of alcohol-related morbidity and mortality among Black men. Data will also improve our understanding of strategies that can improve the implementation of evidence-based care models in non-clinical settings; thus, extending the reach of evidence-based care to communities with the highest need.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as Black
* aged 18 or older
* low income as defined by any indicator (e.g., Medicaid; Earned Income Tax Credit; Children's Health Insurance Plan; subsidized housing; child care subsidies; food stamps; low-income energy assistance; free/reduced lunch program; supplemental nutrition program; Head Start program).

Exclusion Criteria:

-
Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

We clinically observed that some hemodialysis patients had corneal epithelial dryness, shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously affected the effect of surgery, and it is necessary to study the ocular surface characteristics of hemodialysis patients. In this study, we examined the ocular surface and analyzed and investigated the characteristics of the ocular surface in hemodialysis patients to provide a basis for ocular surface intervention or treatment in hemodialysis patients before ocular surgery in clinical practice.

This study is a clinical case-control study. A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .All the subjects in the hemodialysis group (n = 36, 72 eyes) and the normal group (n = 36, 72 eyes) were investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.

Eligibility Criteria:
the hemodialysis group Inclusion Criteria:

* Older than 18
* Hemodialysis patient
* The subject understands the purpose of this clinical trial and agrees to sign an informed consent form.

the hemodialysis group Exclusion Criteria:

* Previous history of ocular trauma or surgery
* History of wearing contact lenses
* Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears
* Eyelid abnormalities (such as eyelid insufficiency, entropion and ECTROPION, tumor, severe trichiasis)
* There have been peritoneal dialysis, kidney transplant surgery patients.

the normal group Inclusion Criteria:

* Older than 18
* Healthy people do not have other systemic diseases, such as diabetes and hypertension
* The subject understands the purpose of this clinical trial and agrees to sign an informed consent form.

the normal group Exclusion Criteria:

* Previous history of ocular trauma or surgery
* History of wearing contact lenses
* Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears.
Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)

The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.

Participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. Before and after the intervention, the patients will undergo:

* measurement of fasting glucose and glycated hemoglobin
* Indirect calorimetry
* oral glucose tolerance test
* intravenous glucose tolerance test
* quality of life and diet-related questionnaires
* 72-hour food records

At the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.

Eligibility Criteria:
Inclusion Criteria:

* T2D for less than 6 years;
* age 18-65 years;
* both genders;
* BMI 27-45 kg/m2;
* HbA1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs).

Exclusion Criteria:

* type 1 or secondary/genetic diabetes;
* treatment with insulin, Glucagon-Like Peptide-1 agonists, Gastric Inhibitory Peptide/GLP-1 co-agonists, or pioglitazone;
* weight loss \>5% within the previous 6 months;
* eGFR \<30 ml/min/1.73m2;
* myocardial infarction within the previous 6 months;
* severe heart failure (NYHA III-IV); eating disorder; substance abuse;
* severe depression;
* known cancer;
* pregnancy.
Supplementary Oxygen in Surgical and Medical Wards Evaluated by 30-day Mortality

This study evaluates the use and effects of supplementary oxygen in surgical and medical wards on patients admitted to a hospital in the capital region of Denmark. The population will be divided in to three groups according to their oxygenation status. The main outcome will be 30-day mortality, with secondary outcomes being Length of stay, 30-day admission to ICU, 30-day reoperations, 30-day readmission, and peak values within 30-days of C-reactive protein, S-Creatinine, Troponin.


Eligibility Criteria:
Inclusion Criteria:

* Admission date between 1st of January 2014 to 29th of December 2014 on a hospital in the capital region of Denmark
* Age ≥18
* Unique (first) admission in database for either:
* Hip fracture requiring surgery
* Chronic obstructive pulmonary disease in exacerbation
* Acute mycardial infarction
* Open abdominal surgery

Exclusion Criteria:

* No data on saturation within 48 hours after
* Admission (Medical patients)
* Discharge from the post anaesthesia care unit (Surgical patients)
* No data on primary outcome (30-day mortality)