cyrilzakka/clinical-trials huggingface dataset:
Glaucoma Laser Trial (GLT) Glaucoma Laser Trial Followup Study (GLTFS)

To compare the safety and long-term efficacy of argon laser treatment of the trabecular meshwork with standard medical treatment for primary open-angle glaucoma.

During the last decade, argon laser trabeculoplasty (ALT) has often been used instead of surgery as the treatment of choice in cases of open-angle glaucoma that could not be controlled by drugs. ALT treatment consists of tiny laser burns evenly spaced around the trabecular meshwork. It sometimes has been found to be effective in controlling glaucoma, although many eyes still require some medical treatment.

The Glaucoma Laser Trial (GLT), a randomized, controlled clinical trial, was conducted to determine whether ALT is effective in patients with newly diagnosed, primary, open-angle glaucoma. Each of the 271 patients in the trial received argon laser treatment in one eye and standard topical medication in the other eye. The eye to be started on medicine and the eye that would get the laser treatment were randomly selected. The Glaucoma Laser Trial Followup Study was a followup study of 203 of the 271 patients who enrolled in the Glaucoma Laser Trial. By the close of the Glaucoma Laser Trial Followup Study, median duration of followup since diagnosis of primary, open-angle glaucoma was 7 years (maximum, 9 years).

The argon laser treatment was done in two sessions 1 month apart, with one-half of the trabecular meshwork treated with 45 to 55 laser burns in each session. Patients were seen for a followup visit 3 months after the first laser treatment and every 3 months thereafter for a period of at least 2 years. At each visit, examination of the eyes included a check of intraocular pressure and visual acuity. Visual field examinations were performed 3, 6, and 12 months after randomization and annually thereafter. Disc stereo photographs were taken 6 and 12 months after randomization and annually thereafter.

The results of these examinations determined whether treatment should be changed. If the pressure in either eye had not been reduced to the desired level, the physician changed the medication in the eye treated with drops or started the use of drops in the laser-treated eye according to a standardized procedure being used in the trial. If intraocular pressure was still not successfully reduced, surgery or further laser treatment may have been required.

Eligibility Criteria:
At the time of recruitment, patients had to be at least 35 years old with an intraocular pressure of at least 22 mm Hg or greater in each eye and evidence of optic nerve damage in at least one eye.
Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)

In order to understand how pharmacokinetics and immunological inactivation affect the therapeutic efficacy of Asparaginase (ASP), it is of help and advised in the frame of clinical font-line protocols to monitor the enzymatic activity by measuring the serum ASP levels in the days following the administration of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent according to ICH/EU/GCP and national local laws
* Age 18 - 65 years
* Diagnosis of untreated Ph- ALL entering treatment including PEG-ASP in induction and consolidation
* ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by pre-existing comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures

Exclusion Criteria:

* Diagnosis of Burkitt's leukemia
* Down's syndrome
* Adults with Ph+ ALL
* Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV)
* Severe liver disease with serum bilirubin \>3 mg/dL and/or ALT \>3 x upper normal limit (unless attributable to ALL)
* Kidney function impairment with serum creatinine \>2 mg/dL (unless attributable to ALL)
* Severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan
* Presence of serious, active, uncontrolled infections
* Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study.
* Pregnancy
* Men and women should use effective contraception during treatment and for at least 6 months after Asparaginase discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with Asparaginase and should not be restarted after discontinuation of Asparaginase
Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations.

The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic PD.
* Patients with a Modified Hoehn and Yahr stage \<3.

Exclusion Criteria:

* Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
* Patients with a clinically significant or unstable vascular disease.
* Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
* Patients with a Mini Mental State Examination (MMSE) score ≤24.
* Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.

Other inclusion and exclusion criteria may apply.
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia

The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

1. Participants diagnosed with hypertriglyceridemia.
2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.

Exclusion Criteria:

1. Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
2. Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
3. Participants with, or with a history of, pancreatitis.
4. Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
5. Participants taking both anti-coagulants and anti-platelets.
6. Participants receiving dual antiplatelet therapy (DAPT).
7. Participants taking direct oral anticoagulants (DOAC) or warfarin.
Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools

This study uses the Physical Frailty Phenotype (PFP) as the diagnostic criterion for frailty and aims to explore the frailty screening scale FRAIL (The FRAIL Scale), Tilburg Frailty Index (TFI) and geriatric screening. Screening performance of Tool-8 (Geriatric-8, G-8) in breast cancer patients, to compare the predictive validity of different frailty screening scales for adverse health outcomes in breast cancer patients, and to select appropriate frailty screening methods for breast cancer patients in my country Screening scale.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast cancer
* Age ≥50 years old
* the treatment plan discussed by MDT includes surgery and chemotherapy
* can walk on their own (with the assistance of walking aids)

Exclusion Criteria:

* Communication disorders
* Mental disorders that can't cooperate normally
* Combined with other malignant tumours
* Terminal stage of the disease
Peer Education on HPV: Impact on Health Sciences Students' Knowledge, Awareness, and Concern

According to the World Health Organization (WHO), 400 million treatable sexually transmitted diseases (STDs) such as syphilis, chlamydia and human papillomavirus (HPV) occur each year in people aged 15-49, mostly in developing countries. As HPV is a sexually transmitted virus, it has been shown to be the most important aetiological factor in cervical cancer in women (99.7%). Vaccination and education of young people about sexuality and STDs are very important in the prevention of HPV. In this respect, the aim of this study was to find out the level of knowledge, concern and awareness of HPV infection among university students and to increase their awareness by informing them about the subject through their peers. The study was conducted as a pre-test and post-test one-group study. The sample of the study consisted of all final year students of Physiotherapy and Rehabilitation (85 students), Nutrition and Dietetics (60 students), Audiology (35 students), Child Development (80 students), Health Management (44 students) and Social Work (45 students) studying in the spring semester of the 2023-2024 academic year. The students were trained by the Gynaecology Nursing Intern student group (9 students) of the Department of Nursing. Data were collected using the Sociodemographic Characteristics Form, the HPV Knowledge Scale and the Human Papilloma Virus Awareness and Concern Level Scale (HPV-FAS). The relevant forms and the consent form were completed by the students before, after and one month after the training.


Eligibility Criteria:
Inclusion Criteria:

* All individuals who are senior students in the Faculty of Health Sciences departments and who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Individuals who did not complete the study and did not speak and understand Turkish were excluded from the study.
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated T-lineage or precursor B-lineage ALL
* Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
* Written informed consent
* Treatment according to DCOG ALL 10 protocol

Exclusion Criteria:

* Mature B-lineage ALL
* Patients with secondary ALL
* Known allergy to any ASNase preparation
* General health status according to Karnofsky / Lansky score \< 40%
* Pre-existing known coagulopathy (e.g. haemophilia)
* Pre-existing pancreatitis
* Liver insufficiency (Bilirubin \> 50 µmol/L; SGOT/SGPT \> 10 x ULN)
* Other current malignancies
* Pregnancy (planned or existent), breast feeding
MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC

Seagull is a phase Ⅱ study designed to investigate the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy vs adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC

In the phase II trial, the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy will be compared with that of standard adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with age ≥ 18 years old, gender is not limited.
2. Histologically confirmed primary NSCLC, postoperative stage is IIA, IIB, IIIA or T3N2IIIB.
3. Receiving complete resection
4. Paraffin-embedded sections (10-15 pieces) or fresh frozen tissue are required.
5. ECOG score of 0 or 1.
6. Females of childbearing age should take appropriate contraceptive measures from screening to 3 months after discontinuation of study treatment and should not breastfeed. The pregnancy test was negative before starting dosing.
7. Male patients should use barrier contraception from screening to 3 months after discontinuation of study treatment.
8. The subjects themselves participated voluntarily and signed the informed consent in writing.

Exclusion Criteria:

1. The patient has received immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4, other immunotherapy or systemic immune modulators (including but not limited to interferon, IL-2 and TNF etc).
2. Histopathology with small cell or large cell endocrine tumor component.
3. Harboring EGFR sensitizing mutation or ALK gene translocation
4. History of other malignant tumors, except for non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and no evidence of any disease for \>5 years after the last treatment.
5. At the start of the study treatment, there are residual toxicities of the previous treatment that are greater than CTCAE 1 and have not been alleviated, except for alopecia and grade 2 neurotoxicity caused by previous chemotherapy.
6. Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, active bleeding, active infection including hepatitis B, C, HIV, etc., which the investigator considers unsuitable to participate in the study or affect the trial program compliance.
7. History of ILD, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease
8. Insufficient bone marrow reserve or organ function.
9. History of hypersensitivity reactions to any active or inactive ingredient of tislelizumab or to drugs that are chemically similar to tislelizumab or in the same class of tislelizumab.
10. Patients who, in the judgment of the investigator, may not comply with the procedures and requirements of the study.
11. Patients who, in the investigator's judgment, have any condition that compromises patient safety or interferes with the evaluation of the study.
The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project

Allergic rhinitis is one of the most common inflammatory conditions of the upper airway mucosa, especially in the pediatric population with a prevalence of approximately 25%. It is among the most common chronic inflammatory diseases globally and is caused by IgE-mediated reactions to inhaled allergens, often co-occurring with asthma and causing severe burdens and disabilities worldwide. Allergic rhinitis can in fact seriously compromise the quality of life, significantly influencing school performance, social life and the quality of sleep. It is known that the most common symptoms characterizing allergic rhinitis (itching of the nose, sneezing, rhinorrhea and nasal/sinus obstruction) are partly overlapping with those due to a condition of deviation of the nasal septum and a recent study has shown how 87 % of patients with persistent allergic rhinitis are affected by at least 1 of the 7 types of nasal septum deformity. Deviation of the nasal septum is a very frequent anatomical disorder and is present in up to 48% of children and adolescents in the general population. The deviation narrows the affected nostril canal, reducing the flow of air that passes through the nostrils, predisposing to chronic mucosal inflammation with inflammatory infiltrate and in turn increasing the risk of developing chronic rhinitis and sinusitis. There are no data in the literature that correlate nasal septum deviation with an increased risk of developing allergic rhinitis. Given these premises, the ARHINASD (Allergic Rhinitis in pediatric topics with Nasal Septum Deviation) study was designed with the primary objective of evaluating the presence of allergic rhinitis in a sample of patients with and without deviation of the nasal septum.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian ethnicity
* both sexes
* age between 6 and 14 years
* written informed consent.

Exclusion Criteria:

* Non-Caucasian ethnicity
* Age \<6 and \>14 years

Concomitant presence of:

* chronic diseases
* malignancies
* immunodeficiency
* chronic infections
* autoimmune diseases
* chronic inflammatory intestinal diseases
* celiac disease
* genetic diseases
* metabolic diseases
* cystic fibrosis
* chronic pulmonary diseases
* malformations of the cardiovascular system
* malformations of the respiratory system
* malformations of the gastrointestinal system
* neuropsychiatric disorders
* neurological diseases
* obesity
* eosinophilic diseases
* antibiotics use in the last 7 days
* cortisone use in the last 7 days
* antihistamines use in the last 7 days
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)

Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
* No history of diabetes and 100 \<=LDL-C \<=250 mg/dl

Exclusion Criteria:

* Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
* Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Uncontrolled hypertension
* Unstable angina
FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage

FAITH study is a multicentre retrospective analysis study that aims to understand the burden of ICH related to FXa inhibitors and the current treatment approaches in country/countries where specific reversal agents are not available yet. The results of this analysis will improve our understanding of FXa inhibitor-related ICH, its socioeconomic impact and factors associated with negative outcomes in real-world settings. The insights gained can inform clinical decision making and potentially lead to strategies to optimise the use of FXa inhibitors, increase the availability of specific reversal agents and improve patient safety and outcomes.

FAITH is a retrospective, non-interventional, multicentre cohort study that will retrieve the data from medical records of adult patients who were hospitalised with confirmed diagnosis of ICH while being treated with FXa inhibitors. The primary objectives of the study is to describe the characteristics and hospital outcomes of hospitalised patients with FXa inhibitors-related ICH in real-world settings. Data of consecutive patients admitted on or after 1 January 2021 and by 30 June 2023 will be retrieved. The index date is defined as the date of hospital admission.The identification of ICH will be based on the CT/MRI scan records and according to the ICD-10-CM diagnosis code. To establish the causal relation between FXa and ICH, the study will include only patients who were determined in the medical records to have taken oral FXa inhibitors.The historical data will be followed up from the index date (the date of hospital admission) until the earliest date of death, lost to follow-up or up to 6 months.The 6-month follow-up period will allow for the assessment of the disability rate and the need for supportive care among survivors.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age at the time of hospital admission.
* Patients presented with a spontaneous or traumatic haemorrhage into any intracranial compartment. The diagnosis of ICH will be based on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan and according to the ICD-10-CM diagnosis code.
* Patients who were determined in the medical records to have taken a dose of oral FXa inhibitors within 24 hrs before hospital presentation that warranted reversal of anticoagulant activities.

Exclusion Criteria:

* Patients who were treated with andexanet alfa.
* Patients who were enrolled in any clinical trials during the study period.
Polypharmacy Among Internal Medicine Patients

The World Health Organisation Patient Safety Challenge: Medication Without Harm has brought our attention to the importance of medication-related harm as a global public health issue. One of the major contributing factors is polypharmacy, the usage of multiple medicines at the same time. People are getting older and living longer with chronic diseases; they need more medications, which frequently leads to polypharmacy. Subsequently, they are at more risk of medication-related harm. The planned project is an epidemiological study on polypharmacy, medication appropriateness, risk factors, and clinical outcomes post-discharge from a hospital for internal medicine patients.

The study group hypothesise that pre- and post-admission polypharmacy and potentially inappropriate prescribing is common, especially among older patients, patients with a high comorbidity and frailty burden. Our hypothesis is additionally that preadmission polypharmacy and potentially inappropriate prescribing is associated with higher short- and long-term mortality, a longer primary hospitalization length of stay, and a higher risk of readmission.

This is an observational, retrospective, single-centered study using clinical data from the patient's medical record from the hospital, the national prescription database of the Directorate of Health, and the ICD-10 codes from primary care records. For this analysis, medicines will be classified into drug classes based on the first five characters of their WHO Anatomical Therapeutic Chemical (ATC) code. The prevalence (pre) and incidence (post) of polypharmacy (≥5 or more regular medicines) and hyper-polypharmacy (≥10 regular medicines) will be calculated. Potentially inappropriate prescribing will be assessed in individuals ≥65 years, applying Beers 2019, Start and Stopp 2014, explicit prescribing criteria. The analysis will be restricted to older individuals, as Beers criteria have not been validated in younger age groups. The anticholinergic burden will be assessed for all individuals ≥18 years will be assessed by applying the anticholinergic burden scale, and the PRIME tool will be applied to predict the likelihood of medication-related harm post-discharge. The PRIME tool consists of eight variables drawn from clinical, medication, and psychosocial domains. Applied at the point of discharge, it provides the absolute risk of an individual older adult experiencing medication-related harm during the eight weeks after discharge from acute hospital admission. This stratification is important in order to deliver targeted interventions in resource-limited healthcare settings.

Eligibility Criteria:
Inclusion Criteria:

* Population-based cohort study that included all patients ≥18 years hospitalized in internal medicine ward at Landspitali - The National University Hospital of Iceland during the study period 1st January 2010 and 31st December 2020

Exclusion Criteria:

* Under 18 years of age