cyrilzakka/clinical-trials huggingface dataset:
Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition

The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new software (glaucoma premium module) with the well established peripapillary RNFL thickness measurements in patients with primary open angle glaucoma.

The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with the new software (method B) and with the previous method of measurement (method A) in patients with glaucoma.

It is a prospective, not blinded, not randomised, monocentric study. Inclusion of 50 patients with a diagnosis of primary open angle glaucoma (POAG), that will be recruited from the ophthalmology outpatient department of the UniversityHospital Zurich, Switzerland. All patients will undergo a full ophthalmic examination including measurement of refraction, best corrected visual acuity, examination of anterior and posterior compartment and measurement of the intraocular pressure. On the same day they will have 3 OCT examinations with a new method of measurement (method B).On the same day the first 10 patients will undergo also 3 OCT examinations with the previous method (method A) and they will get an other 3 OCT examinations with method B by a second observer. For this 10 patients the next consultation (3 months +/- 1 month) the 3 OCT examinations with method B will be repeated by the first observer.

Primary objectives are coefficient of variations (COV) of method A and B; Intra-class-correlations (ICC) of method A and B.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of POAG glaucoma
* male and female patients aged 18 years or older, no upper limit
* written informed consent
* visual acuity of more or equal to 0.5 Snellen
* refractive error between + /- 6.00 D spheric and under or equal than 2.00 D cylindrical

Exclusion Criteria:

* history of surgery other than uncomplicated cataract surgery
* disease affecting cornea, anterior compartment, lens, vitreous body
* history of severe ocular disease, particularly diseases affecting the optic nerve, other than glaucoma
* history of ocular trauma
Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma.

Histone deacetylase(HDAC) inhibitor has been used in relapsed or refractory peripheral T-cell lymphoma.There are no international studies of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma. Therefore, this study intends to select the oral HDAC inhibitor Chidamide combined with lenalidomide for relapsed or refractory peripheral T-cell lymphoma, and explore its efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* peripheral T cell lymphoma (PTCL);
* no remission or relapse after at least one previous systemic treatment；
* at least one assessable lesion；
* 18-75 years;
* ECOG PS 0-2;
* proper functioning of the major organs;
* expected survival time ≥3 months.

Exclusion Criteria:

* previous received treatment of HDAC inhibitor or lenalidomide;
* central nervous system (CNS) involvement;
* serious heart problems;
* known allergies to experimental drug ingredients;
* diagnosed with or receiving treatment for a malignancy other than lymphoma;
* uncontrolled active infection, with the exception of tumor-related b-symptom fever;
* unable or unwilling to receive antithrombotic therapy;
* history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;
Plant Stanol Esters and COVID-19 Vaccination Response

Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI has previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effect on the immune system, people with overweight or obesity might benefit from consuming plant stanols prior to receiving the COVID-19 vaccination. The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients. The main study endpoint is vaccination response to a COVID-19 vaccine. Secondary endpoints include amongst others hematological, inflammatory and immunological parameters (e.g. hs-CRP, leukocyte differential count) and metabolic markers (e.g. blood lipid profiles, plasma glucose, serum insulin, HOMA-IR).


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 18 years or older
* BMI between 27 and 35 kg/m2
* Currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to keep the intake of fish oil and vitamin supplements constant

Exclusion Criteria:

* Already received COVID-19 vaccination
* Already had a positive test for COVID-19 (this includes all types of tests, e.g. PCR tests or antibody tests)
* Allergy to an ingredient of the mini drinks
* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
* Pregnant women
* Breastfeeding women
* Excessive alcohol use (\>20 consumptions per week)
* Regular use of soft or hard drugs
Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response

Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.

* Controlled trial study.
* All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups.

group 1 : 15 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 20 IU/kg of human rabies immune globulin (HRIG).

group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 for rabies neutralizing antibody titers (RNab).

The GMTs of RNab among both groups would be analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers age 18-60 years.

Exclusion Criteria:

* received prior rabies immunization
* pregnancy
* immunocompromised conditions
Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction

Among patients early following ST-segment (ST) elevation myocardial infarction, transcutaneous vagus nerve stimulation is associated with a reduce of the burden of premature ventricular contractions in the first 40 days post-myocardial infarction (MI).

The above hypothesis will be tested with a randomized, prospective, parallel, single-blind clinical trial. The expected study duration is approximately 12 months from the time the first subject is enrolled (planned for June 2023) to the time of study's termination date (December 2024). Patient enrollment is planned to take place at two major centers in Greece. The researchers will obtain approval by the institutional review board (IRB).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥18 years
* ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention
* Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule

Exclusion Criteria:

A patient will be excluded from the study if one or more of all the following criteria are present:

* \< 3 months after prior ablation
* Patients on amiodarone
* Patients with known thyroid issues, on renal-dialysis
* Life expectancy of \< 12 months
* Complex congenital heart disease
* Cardiogenic shock
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
* Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
* Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker
* Complete heart block or trifascicular block without an implantable pacemaker
* Recurrent vasovagal syncope
* Pre-existing implantable cardioverter-defibrillator (ICD)
* Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded))
* On the heart transplant list
* Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications)
* Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)
Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma

This research is being done to find out if altering the immune system by giving activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years old;
* Patients with active myeloma requiring systemic treatment;
* Newly diagnosed patients. Relapsed myeloma patients that have not previously had a transplant;
* Meeting criteria for high-risk disease;
* Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 (see Appendix C).
* Meet all institutional requirements for autologous stem cell transplantation;
* The patient must be able to comprehend and have signed the informed consent;
* Patients must have had \> than PR after last therapy.

Exclusion Criteria:

* Diagnosis of any of the following cancers:

  * POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes);
  * Non-secretory myeloma (no measurable protein on Serum Free Lite Assay);
  * Plasma cell leukemia;
* Diagnosis of amyloidosis;
* Failed to achieve at least a partial response (PR) to latest therapy;
* Previous hematopoietic stem cell transplantation;Patients can have had prior relapsed disease as long as they have never been previously transplanted;
* Known history of HIV infection;
* Use of corticosteroids (glucocorticoids) within 21 days of bone marrow collection;
* Use of any myeloma-specific therapy within 21 days of bone marrow collection;
* Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration;
* Participation in any clinical trial within 28 days of registration on this trial, which involved an investigational drug or device;
* History of malignancy other than multiple myeloma within five years of registration, except adequately treated basal or squamous cell skin cancer;
* Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is permitted.
* Human T-lymphotropic virus (HTLV) 1 or 2 positive;
* Known hypersensitivity to Prevnar or any of its components;
* Contraindication to phosphodiesterase-5 inhibitors (e.g. currently on nitrates).
Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced NSNSCLC

The purpose of this study is to compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC.

S-1 consists of Tegafur,Gimeracil and Oteracil Potassium. Tegafur is metabolize to Gimeracil，and slows down the metabolism of 5-FU in high DPD enzyme expression tumor cell, so that 5-FU could bring the antimetabolic fiction more efficiently. Plenty of studies support that S-1 shows a desirable effect on advanced non-squamous NSCLC, and S-1 is more convenient compare with Pemetrexed. The curative effect of Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC has been proved to be valid. The purpose of our study is to explore whether S-1 could replace Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Histological or cytological documented
3. NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.1.
4. Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD.
5. Candidates's expected survival time should be greater than or equal to 3 months with ECOG performance status 0-1, adequate haematological and Hepatic- renal function, and cardiac function.
6. At least one measurable tumor lesion (maximum diameter has to be greater than 10mm scan by CT or MRI) or malignant lymph node (15mm in short axis), and must not be accepted radiotherapy.
7. No any other following malignancy or any serious complication caused by metastatic encephaloma.
8. No any gastrointestinal diseases that could reduce the drug absorption.
9. Female: Candidates who have any chance to be pregnant must accept pregnancy tests 72 hours before therapy, and take medical allowed contraceptives during therapy or in 3 mouths after therapy. Pregnancy tests results must be negative.Lactation female are not included.
10. Male: Be sterilized or take contraceptives during therapy or in 3 mouths after therapy.

Exclusion Criteria:

1. Any unstable systemic disease
2. Patients with exposure to any recent anticancer therapy outside of this trial.
3. Pregnant or breast-feeding women
A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria

This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of chronic inducible urticaria for at least 3 months.
* Positive response following provocation using the TempTest or FricTest at Screening and Day 1.

Exclusion Criteria:

* History of diseases other than chronic inducible urticaria or chronic spontaneous urticaria with urticaria or angioedema symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema.
* Concurrent use of certain medications, including antihistamines.
* Any clinically significant disease, or other skin disease or skin markings (e.g., extensive scarring, tattoos), that might confound the evaluation of safety or efficacy.
Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.

This PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'. This PMS is to assess the safety and effectiveness after administrating Mucosta®SR Tab. Each subject would be observed for 2 weeks from baseline, if possible. As this PMS is an observational study in practical medical environment, the subject's follow-up is recommended but not obligatory and must be left up to the judgment of the investigator.

According to the "Standards for Re-examination of New Drugs, etc." of South Korea, this PMS is conducted in order to collect safety and efficacy information for patients prescribed with Mucosta®SR Tab. under actual conditions of treatment during the re-examination period of Mucosta®SR Tab. 150mg (Rebamipide)

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis.
2. Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
3. Patients who have given a written informed consent to participation of this PMS and use of personal information after execution of the contract with the surveillance study site.

Exclusion Criteria:

1. Patients with prior history of prescription with Mucosta®SR Tab.
2. Patients with hypersensitivity to Rebamipide or its component ingredients.
3. Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease

This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Type 2 diabetes treated with at least one antihyperglycemic medicine for 12 months
* Have diabetic kidney disease and receiving one of two specific medicines used to treat high blood pressure or diabetic kidney disease for at least 3 months
* Estimated Glomerular Filtration Rate (eGFR) of 25 to 70 milliliter per minute per 1.73 square meter (mL/min/1.73 m²) (as determined by the Chronic Kidney Disease Epidemiology Collaboration equation) and a urinary albumin/creatinine ratio (UACR) \>300 milligram per gram (mg/g) and \<5000 mg/g

Exclusion Criteria:

* Too high blood pressure when you enter the study
* Some specific medicines used to treat high blood pressure or diabetic kidney disease
* Frequent high blood glucose levels
* Renal transplant or past history of dialysis
* Nonsteroidal anti-inflammatory drugs (NSAIDs)
* Had a special X-ray in the past 30 days which involved also receiving an injection of dye into the vein
* Major surgery within 8 weeks of study entry or will require major surgery during the study
* Some types of vaccination
* Shingles or currently have symptoms of a cold sore
* Serious viral, bacterial, fungal, or parasitic infection, or a urinary infection, Tuberculosis (TB)
* Human immunodeficiency virus (HIV) infection- the virus that causes Acquired immunodeficiency syndrome (AIDS)
* Have or had some blood disorders, enlarged lymph glands or spleen, or some cancers.
* Serious circulatory, breathing, liver, stomach or bowel problems, neurological or psychiatric disorders
* Heart attack or heart failure, or a stroke
* Other serious disorders or illnesses
* Electrocardiogram (ECG) heart trace abnormalities
* Alcohol or illegal drug abuse
* Donated more than 500 mL of blood in the last 30 days (no blood donations allowed during the study)
* Pregnant or breastfeeding
A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery

The purpose of this study is to determine whether electroacupuncture preconditioning would provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation in children undergoing CPB for repair of congenital heart defects.

2-12 years old children undergoing repair of congenital heart defects were included, except for those with server pulmonary arterial hypertension, chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders were excluded. Children were equal randomized to EAPC(electroacupuncture preconditioning)or control group. Electroacupuncture was administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery in EAPC group. Control patients underwent sham placement of the electrode the arm without stimulation. The duration of cardiopulmonary bypass and aortic cross-clamp time was recorded. Myocardial injury was assessed by cardiac heart-type fatty acid-binding protein (HFAP) and cardiac troponin I (cTnI\>0.40 ng/mL). 8-isoprostane , C-reactive protein, cytokines were measured pre- and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Aged 2-12 years children undergoing repair of congenital heart defects without server pulmonary arterial hypertension or systematic disease.
* Get an informed consent from parental.

Exclusion Criteria:

* Patient's age is less than 2 years or more than 12 years.
* Patient with isolated atrial septal defect undergoing repair via thoracoscope completion.
* Patients with chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders.
* Patients without an informed consent from parental.