cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of a New Immunoglobulin E (IgE) Assay Method

The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.

Allergy is a raising public health problem. Specific IgE assays are useful tools to investigate the physiopathology of allergies. This method is achieved mainly by the ImmunoCAP enzyme immunoassay technique. This is an expensive test that requires a significant amount of blood. This is a limitation particularly in children. The time to get the results is long and a second consultation has to be scheduled in order to communicate the results to the patients. The main objective of this study is to assess the feasibility of a new specific IgE assay, named LuLISA, using a bioluminescence technique in urine and blood samples from pediatric and adult allergic population. This technique was recently published for the quantification of IgE against two peanut allergens and needs to be extended for the detection of other major allergens. A secondary objective is the evaluation of the time needed to obtain results.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 6 months' old or older
* Sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug proven by:

  * positive skin test (s)
  * and / or IgE specific (s)\> 0.1 kUA / L
  * and / or anamnesis in favor of an allergic reaction of mediated IgE
* Social coverage up to date

Exclusion Criteria:

* Children younger than 6 months'old
* Children's weight less than 10 kg
* Pregnant or breastfeeding women
* Patients with cystic fibrosis
* Patients with dysimmune or autoimmune pathology
* Anamnesis in favor of a delayed allergy or a contact allergy.
Effects of Losartan on Insulin Resistance in Patients With Heart Failure

The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.

Chronic heart failure (CHF) is associated with marked insulin resistance, characterized by both fasting and stimulated hyperinsulinemia. Furthermore, insulin resistance is a predictor of CHF and associated with more severe disease and a worse prognosis in patients with CHF. In CHF patients, therefore, insulin resistance is not merely a function of adiposity and may have implications in the pathophysiology of CHF disease progression. Angiotensin II negatively modulates insulin-mediated actions by regulating multiple levels of the insulin signaling cascade such as the insulin receptor, IRS, and PI3-kinase. Furthermore, both ACE inhibitors and angiotensin II receptor blockers (ARB) improve glycemic status not only in patients with type II diabetes but also in patients with hypertension and the metabolic syndrome. On the other hand, it is well known that some cytokines, such as TNF-α, are involved with pathophysiology of insulin resistance and CHF. However, it is still unclear whether the ARB improves insulin resistance in CHF patients already treated with ACE inhibitors and whether there is the relationship between insulin resistance and inflammatory cytokines in CHF patients already treated with ACE inhibitors. Therefore, the purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* chronic stable heart failure

Exclusion Criteria:

* renal dysfunction or under treatment with antidiabetic agents
haMSter: a Novel Smartphone Communication Tool for People With MS

haMSter is a smartphone app that tracks validated patient reported outcome measures (PROMs) in people multiple sclerosis (MS). In this study, 50 patients with MS will receive this app for 6 months and be asked to fill out the PRO questionnaires on their Smartphone.

Endpoints include the adherence to this app and satisfaction with this Intervention.


Eligibility Criteria:
Inclusion Criteria:

* Any MS according to MacDonald criteria
* informed consent

Exclusion Criteria:

- language barriers
Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain

Chronic neck pain (CNP) is defined as pain or intense discomfort in the lateral or back of the neck with an establishment and/or persistence period of over 12 weeks.

The socio-economic system is seriously affected by chronic neck pain due to direct and indirect costs on the health system Physical exercise is used to improve physical function and reduce the symptoms of pain and stiffness due to chronic neck pain.

It has been demonstrated that therapeutic exercise in water is effective to improve functional capacity and symptoms in patients with chronic neck pain. In adition, health education and posture is an important component of the overall treatment of neck pain.

Interventions that integrate physical activity, adapted swimming and health education as an intervention for chronic neck pain sufferers have not been found. Furthermore the aim of this study is to analyse the effect of a physiothperapy treatment that combine adapted swimming, therapeutic exercise and health education in patients with chronic neck pain.

Hypothesis: the present intervention will be an effective tool to treat patients suffering chronic neck pain.

Methods: chronic neck pain patients from a community-based centre will be recruite participate in this prospective study.

Intervention: 60 min session: 30 min of land exercise dedicated to improve mobility, motor control, resistance and strengthening of the neck muscles, 30 min of adapted swimming with aerobic exercise keeping neutral neck position by using a snorkel. Health education will be provided by the physiotherapist before and during the sessions using a decalogue on chronic neck pain and constant repetition of brief advice.

Study outcomes: disability (Neck Disability Index), physical and mental health state and quality of life of patients (SF-12 and EuroQoL 5D respectively).

Differences between baseline data and that at the 8-week follow-up were calculated for all outcome variables.

Statistical Analysis: descriptive statistics. Analysis of the normal distribution of the variables using the KS-test. Comparison of variables pre - post intervencición: T-Student for parametric variables and Wilcoxon test for non parametric variables.

Data will be analysed descriptively and for statistical significance using Statistical Package for the Social Sciences (SPSS) (version 17.0 for Windows, Illinois, USA).


Eligibility Criteria:
Inclusion Criteria:

* Suffers Neck Pain for more than 12 weeks.
* Delivery of informed consent.

Exclusion Criteria:

* Neck pain due to an identifiable cause.
* Surgery on the spine in the 12 month
* Traffic accident in the last 3 months
* Cervical radiculopathy
* Pregnancy.
* Patients who suffered a condition that could alter the effects of treatment
* People who could not swim and/or present treatment difficulty.
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
* Eastern Cooperative Oncology Group performance status of 0 to 1.
* Measurable disease according to RECIST v1.1.
* Availability of tumor tissue (fresh or archival) for central pathology review.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

* Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
* Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
* Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is \> 30 Gy within 6 months of the first dose of study treatment.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* History of second malignancy within 3 years (with exceptions).
* Laboratory values outside the protocol-defined range at screening.
* Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
* Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
* Receipt of a live vaccine within 28 days of planned start of study therapy.
* Current use of protocol-defined prohibited medication.
* Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
* Participant who is pregnant or breastfeeding.
Social Workers of Elderly Care in Hungary

In our Research the goal is to examine the level of stress and burnout among social care workers and their causes and effects after COVID-19 pandemic. We would like to examine the migration from work trend and its socio-demographic causes in the light of COVID-19 pandemic among social care workers in Hungary. We would like to analyze the extent of stress and burnout at work after COVID-19 pandemic, as well as the resulting turnover intentions in Hungary among social care workers. Our goal is to validate on hungarian population the Turnover Intention Scale (TIS-6), to measure fluctuation and migration.

A number of stress factors have been identified that affect nurses' burnout and job change, but there is little domestic research on the topic among social workers in connection with the COVID-19 epidemic.

As a result of our research, we expect that higher fear of COVID-19 is associated with lower job satisfaction, increased workplace anxiety, burnout, and increased turnover intentions.

Eligibility Criteria:
Inclusion Criteria:

* Social workers in Hungary, who are actively employed,
* 18 years of age or older
* working in the field of elderly care.

Exclusion Criteria:

* people, who do not have an active employment
* currently have no job
* working online
* non-professional staff working in social care (eg. cleaning, maintenance)
Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)

The Gladius First trial is designed as a single-centre, open, prospective, randomized clinical trial aimed to assess the efficiency and safety of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the antegrade wiring strategy with a first-choice intermediate Gladius guidewire. To this end, consecutive patients referred to CTO PCI with intended primary antegrade wire escalation strategy, will be randomized in a 1:1 fashion to antegrade wiring starting with the Gladius guidewire or antegrade wiring using the standard guidewire escalation strategy.


Eligibility Criteria:
Inclusion Criteria:

* delivery of an informed consent and compliance with study protocol
* CTO of a major coronary artery with at least intermediate difficulty score (J-CTO ≥1) as assessed by invasive angiography
* referral to clinically indicated CTO PCI with intended primary antegrade wiring strategy

Exclusion Criteria:

* in-stent CTO
* unstable angina and/or myocardial infarction
* prior myocardial infarction within 4 weeks before study enrolment
* CTO of a major coronary artery with an easy difficulty score (J-CTO 0) as assessed by invasive coronary angiography
* lack of valid antegrade wire escalation strategy as assessed by 2 independent CTO PCI operators
* chronic kidney disease (defined as eGFR ≤30 ml/min/m2)
* contraindication to antiplatelet therapy and/or heparin
* severe inflammatory disease
* positive pregnancy test or breast-feeding
Gene Therapy for X-linked Severe Combined Immunodeficiency (SCID-X1)

X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in failure of development of the immune system in boys. This trial aims to treat SCID-X1 patients using gene therapy to replace the defective gene.


Eligibility Criteria:
Inclusion Criteria:

1. No HLA identical (A,B,C,DR,DQ) family donor and no HLA identical unrelated donor available within 3 months of diagnosis or patients whose underlying clinical problems and prognosis would be significantly compromised by chemotherapy conditioning (including persisting pneumonitis, protracted diarrhoea requiring parental nutrition, ongoing visceral viral infection (herpes viruses, HSV,VZV,CMV, EBV or adenovirus), systemic BCG infection, virus-induced lymphoproliferation.
2. Diagnosis of classical SCID-X1 based on immunophenotype (absent, or reduced numbers of non-functional T lymphocytes) and confirmed by DNA sequencing
3. Parental/guardian voluntary consent
4. Boys between the ages of 0 and 16
Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe Medical Center

Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. Reviewing the data collected until now may reduce the need for poist natal echography.

Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. The investigator will review all echographies performed in the last ten years. Reviewing the data collected until now may reduce the need for poist natal echography.

Eligibility Criteria:
Inclusion Criteria:

* Newborns who had a cardiac echogenic focus during prenatal pollow-up.

Exclusion Criteria:

* Newborns who did not had postnatal echocardiography due to technical reasons.
Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome

Fasting blood specimens will be taken from the patients with IBS that have inclusion criteria. First, the objectives and method of study will be explained to the patients and informed consent form will be taken from them. They will be divided into 4 groups by an adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress questionnaires will be completed before and after intervention. During 6 weeks, they will receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the other placebo form, both of them and placebo of both. At the end, body mass index ( BMI), serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen receptors will be determined.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 yrs
2. patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria
3. BMI 18-25
4. a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery
5. no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, opium and non-steroidal anti-inflammatory drugs
6. no pregnancy and lactation
7. not athlete or bed rest
8. no history of breast cancer in herself or her family
9. no severe psychosis

Exclusion Criteria:

1. a- use of soy isoflavones or vitamin D one year before the study b- use of soy milk or soy nuts during study
2. diet changes during study
3. use of artificial sweetener 2 days before study
4. no desire to complete the study
5. adverse effect of supplement
6. pregnancy during study
Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects.

Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney transplantation.

Comparative study including

* 20 consecutive patients with Martorell HYTILU
* 10 consecutive patients with Calciphylaxis (calcific uremic arteriolopathy)
* 20 patients with venous ulcer

The following parameters are measured in the blood serum:

White blood count; c-reactive protein; creatinine; calcium (total); free (ionized) calcium; phosphate; albumin; 25-hydroxyvitamin-D; 1-25-dihydroxyvitamin-D; homocysteine; cystatin C alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)

The following parameters are measured in samples of diseased (necrobiotic) skin:

alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)

Eligibility Criteria:
Inclusion Criteria:

* Having Martorell hypertensive ischemic leg ulcer (as defined above) or
* Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or
* Having a venous ulcer (as defined above)

Exclusion Criteria:

* None
A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

This is an open-label, single-sequence, drug-drug interaction study in healthy male and female subjects. There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may increase the exposure of montelukast, flurbiprofen, and digoxin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive, with a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Women of childbearing potential must agree to follow instructions for methods of contraception for the duration of the study

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of arrhythmias or palpitations associated with dizziness or fainting
* History of clinically relevant cardiac disease

Other protocol defined exclusion criteria could apply
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers

This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 year old
* Healthy adult volunteer

Exclusion Criteria:

* Eye disorders including cataracts
* Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
Retrospective Study for Recurrent Nasal Polyposis

A retrospective study for patients with recurrent nasal polypi operated at Otorhinolaryngology Department, Sohag University Hospital will be carried out.

A retrospective study for patients with recurrent nasal polypi operated at Otorhinolaryngology Department, Sohag University Hospital will be carried out. All available information about these patients will be retrieved from our department data base including full personal history, medical history and type of surgery performed with operative details.. Missed patients due to any reason will be excluded from the study during. Complete information about patients' symptoms, onset, progression, severity and duration of recurrence after surgery will be taken from our department data base. Associated factors will be evaluated from data base (asthma, allergy, smoking, Samter's triad, cystic fibrosis, fungal sinusitis, immune status, etc.).

Eligibility Criteria:
Inclusion Criteria:

All patients with recurrent nasal polypi will be include in our study regardless their age and sex.

Exclusion Criteria:

* Exclusion criteria:

Patients with nasal polyps due to underlying neoplasm will be excluded from our study. Also, those with fresh polyps or missed patients during follow up due to any reason are not candidates for our research.
Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response

During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are among the most common causes of this condition.

In recent years, the use of ultrasonography (USG) in anesthesia has become widespread with the rapid advancement of technology. The use of the patient's head is a non invasive method.

This study is aimed to evaluate whether the size of the venous diameter assessed by ultrasonography in our study is an effect on pain and withdrawal response after drug injections.

The study was conducted in patients who underwent surgical procedures under general anesthesia by obtaining consent from the Adnan Menderes University Medical Faculty Ethics Board and written consent from the patients and then being admitted to the ASA I-II age group 18-70 years of age.

Patients with peripheric vascular disease, vasculitis, rheumatologic disease, non-cooperative, under the age of 18 and over 70, ASA III and above, allergic to general anesthetic agents and refusing to participate in the study were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

18- 70 years of ASA (American society of anesthesiology) physical status I- II who were to undergo various elective operations

Exclusion Criteria:

Rheumatologic disease Peripheric vascular disease Vasculitis Patients with chronic pain syndrome, Patients with neurologic deficits, Patients with thrombophlebitis, Patients with difficult venous access, Patients with allergy
Discovering Trends in Chronic Fatigue Syndrome Patients' Clinical Study Experiences

The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

The data collected from this study will help improve future outcomes for all chronic fatigue syndrome patients as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent
* Aged ≥ 18 years old
* No prior treatment for chronic fatigue syndrome

Exclusion Criteria:

* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.