cyrilzakka/clinical-trials huggingface dataset:
A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in China

The purpose of the study is to collect information on how Tresiba® works in patients with type 2 diabetes in China. The study will be based on data already recorded in participants' medical records and no new tests or procedures are required as part of the study. This study does not affect participants' current diabetes treatment. The study will look at data recorded in participants' medical records for approximately the last year. After signing the informed consent form, no further activities will be required from the participants.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent Form (ICF) obtained before any study-related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, aged at least 18 years at the time of signing the ICF.
* Diagnosed with T2D.
* Treated with any OAD(s) or basal insulin ± OAD(s), with or without prandial insulin for at least 20 weeks prior to treatment initiation with Tresiba®.
* The decision to initiate treatment with commercially available Tresiba® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Treated with Tresiba® (with or without OADs, with or without prandial insulin) for at least 20 weeks and have at least one documented medical visit with HbA1c measurement in the first 20 weeks (plus/minus 8 weeks) after Tresiba® initiation. The patient may or may not be treated with Tresiba® at the time of patient selection to this study.
* Minimum available data: age, weight, and sex at the time of Tresiba® initiation, HbA1c (most recent value within 12 weeks prior to Tresiba® initiation and a value in the first 20 weeks \[plus/minus 8 weeks\] after Tresiba® treatment), and duration and type of insulin treatment (for insulin treated patients).

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having signed the ICF.
* Participation (defined as randomisation) in a diabetes clinical trial of an approved or non-approved investigational medicinal product within 20 weeks prior to the treatment initiation with Tresiba® or during the first 28 weeks of treatment with Tresiba®.
* Tresiba® not used in accordance with the local label.
* Patients treated with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® (short-term \[equal to or less than 14 days\] treatment with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® is allowed).
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients

68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted


Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically confirmed prostate cancer;
2. Age range from 18 to 75 years old (including 18 and 75 years old);
3. ECOG score of 0 or 1;
4. Expected life ≥ 6 months；
5. The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration;
6. The subjects are able to maintain good communication with the researchers；understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.

Exclusion Criteria:

1. Known or suspected to be allergic to the investigational drug or any of its components;
2. Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;
3. Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;
4. Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;
5. Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug；
6. Ongoing toxicity \>grade l from previous standard or investigational therapies；
7. Patients with active infections during screening;
8. Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:
9. Other situations where the researchers believe that the subject is not suitable for inclusion in this study.
Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24 hours following the first chest pain.

All the STEMI patients treated by primary PCI (with stent implantation) within the 24 hours following the first chest pain can be included in the GIANT study. After the PCI, they'll receive DAT (Aspirin + Clopidogrel/Prasugrel).

Patients will then be genotyped to determine if they carry one of the CYP2C19 gene variants making them resistant or hyper responder to clopidogrel. The genetic profile of the patients will be communicated to the physician who took care of them so that he can (or not) adjust the thienopyridine treatment (increase of the clopidogrel dosage, switch to prasugrel or switch to clopidogrel). A treatment will be prescribed for 12 months as according to the European guidelines.

One year after the PCI, the patients will have to be available for a follow up visit. They'll be submitted to a VERIFY NOW P2Y12 protocol to determine whether they were compliant to their thienopyridine treatment. A clinical follow up will be also performed to evaluate the cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patient treated within the first 24 hours with primary PCI (with stent implantation)
* Age superior or equal to 18 years old
* Informed consent signed
* Patient volunteer to be submitted to the 1 year visit follow up and to the clinical exams during this visit
* Patient benefiting from French social health system

Exclusion Criteria:

* NONSTEMI patient with high troponin
* STEMI patient treated after the first 24 hours
* Stable / unstable angina or silent ischemia
* Cardiogenic shock
* Oral anticoagulation (Vitamin K Antagonists)
* Contraindication for PCI
* Age inferior to 18 years old
* Life expectancy inferior to 1 year
* Participation in another clinical trial
* No signed informed consent
* Patient not available for the 1 year visit follow up
* Pregnant women
* Known allergy to media contrast that can not be controlled by an adapted treatment
* Known allergy to cobalt chromium alloy
* Left ventricular ejection fraction lower than 30%
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity

This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in obese adolescents age 12-16 years.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 12 years and \< 17 years;
* BMI ≥ the 95th percentile, with documented history of failure to lose sufficient weight or failure to maintain weight loss in a lifestyle modification program;
* If female, must be using adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.

Exclusion Criteria:

* Type 1 diabetes;
* Congenital heart disease; clinically significant ECG abnormality;
* Clinically significant physical exam, vital signs, or laboratory abnormality; clinically significant hepatic or renal disease;
* Estimated Glomerular Filtration Rate (GFR; Schwartz formula) \< 60 mL/minute;
* Clinically significant thyroid dysfunction as evidenced by signs, symptoms, or thyroid stimulating hormone (TSH) \> 1.5 x Upper Limit of Normal;
* Obesity of known genetic or endocrine origin;
* History of bipolar disorder or psychosis, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation;
* Recent weight instability, or prior bariatric surgery;
* History of glaucoma or increased intraocular pressure;
* Current smoker or smoking cessation within 3 months of screening;
* Currently taking or plan on taking any of following medications during the study:

  * Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, gamma-aminobutyric acid (GABA) analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate);
  * Tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), lithium, levodopa, and dopamine receptor agonists;
  * Carbonic anhydrase inhibitors;
  * Insulin, Sulfonylureas (SFUs), glucagon-like peptide -1 (GLP-1) agonists, sodium glucose transporter-1 (SGLT-1), and SGLT-2 inhibitors;
  * Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives;
  * Treatment for hyperactivity disorder; or
  * Over the counter, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight.
Iron and Pollen Allergy in Women

Iron deficiency and anemia are clearly associated with the onset of allergy and allergic diseases, whereas an improved iron status seems to prevent the onset of allergy in humans. Iron-deficiency can be absolute or functional. Functional iron-deficiency occurs during immune activation and may be reflective for the hyperactive state of atopic subjects.

The investigators plan a prophylactic dietary intervention study in atopic/allergic and non-allergic individuals that transport chelated iron to immune cells. Over the course of six months, oral supplementation of placebo or whey protein-bound chelated iron will be given and 1) clinical reactivity 2) iron status and 3) changes in the microflora due to the treatment will be assessed.

There is no state-of-the-art prophylactic treatment for atopy. Once allergy develops, allergens should be avoided, and specific allergen immunotherapy applied. The initial cause of the onset of allergy, namely the immune hyperactive state of the atopic subjects, is not addressed at all. The investigators hypothesize that atopy is defined by a mild functional iron deficiency and that improving the iron status of immune cells will decrease the reactivity of these cells.

In this prophylactic dietary intervention study oral supplementation of placebo or chelated and whey protein-bound iron will be given over the course of six months to allergic and non-allergic women. Changes in 1) the clinical reactivity 2) the iron status and 3) the microflora will be assessed. The study will be the first systematic approach in humans to assess the contribution of iron deficiency to allergy and will be pivotal in supporting the implementation of prophylactic and therapeutic recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy premenopausal women over 18 years of age. Allergic participants should have been diagnosed with allergic rhinitis against birch and/or grass pollen.

Exclusion Criteria:

* Subjects with co-morbidities such as diabetes mellitus, disorders of the liver including hemochromatosis or kidney, autoimmune and metabolic diseases or malignancies or who use medications (e.g. antibiotics, PPIs) that influence the iron, inflammatory or microbial status will be excluded. Further exclusion criteria are pregnancy, lactation, zinc, and iron supplementation and smoking. Subjects with a history of major bleeding (including trauma, surgery, other major blood loss) within the last 2 years and blood transfusion within the last 2 years, or with a history of significant breakthrough bleeding will be excluded. Volunteers will be asked to cease blood donation at least three months before recruitment. Allergics with a history of an allergen-induced anaphylactic shock or with severe, uncontrolled asthma who in the last two years have received allergen immunotherapy or an anti-IgE therapy will be excluded.
Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 20 Patients

The nature of trigeminal neuralgia (TN) is fluctuating and patients can experience periods of complete remission of pain as well as periods with excessive pain. TN is often triggered by innocuous intra- and extraoral stimuli such as chewing. Since the first-line prophylactic drugs, i.e. carbamazepine and oxcarbazepine, are administered orally, medical treatment of TN can be problematic in periods of exacerbation. In cases of severe exacerbation, patients oftentimes become dehydrated and anorectic as eating and drinking will evoke pain. Treatment with drugs administered intravenously is needed in such situations. Phenytoin was the first drug to be used for TN but it is rarely used as long-time preventative because of frequent side-effects associated with long-term use. However, phenytoin has the advantage over other drugs, that it can be administered also intravenously as fosphenytoin (the prodrug of phenytoin).

By clinical experience the efficacy is very good. However, evidence of the treatment is lacking as only case reports including a total of 5 patients described the effects and side effects with pain relief lasting two days. By providing solid observational evidence, the treatment can be considered for incorporation in local and international treatment guidelines.

The aim of the study is to test the hypothesis that fosphenytoin loading reduces TN pain with at least 50 % in 80% of patients with trigeminal neuralgia experiencing exacerbation of TN pain.

The study is a descriptive prospective observational pilot study with 3 months followup period.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Must be able to give signed informed consent prior to study entry.
* Must fulfill the ICHD-3 diagnostic criteria for TN. Both patients with purely paroxysmal TN and patients with TN with concomitant persistent facial pain will be included.
* MRI of the brain, brainstem and trigeminal nerve or patient is willing to undergo MRI in the days and weeks following admission.
* Must be able to adhere to the study protocol and understand either Danish or English.

Exclusion Criteria:

* Psychiatric or mental illness or condition that might interfere with the ability of the patients to fill in the Informed Consent.
* Contraindications for phosphenytoin loading such as sick sinus syndrome, atrioventricular block and hepatic insufficiency.
Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy

This study evaluate the effectiveness of the Virtual Reality Educational Program (RVEP) in the Paediatric Surgical Prehabilitation Unit to reduce the perioperative anxiety in children who undergo to elective surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.

During preoperative time, anxiety is one of the most frequent problems in children, causing an important health problem as long with pain. In the surgical fields there are two especially stressful moments for the child, the first one is the parent´s separation, and the second is the anaesthetic induction, which in up to 42% of cases can be traumatic.

Methods to treat paediatric anxiety have evolved in the last decades. Pharmacological therapy is one of the most used methods to treat anxiety in the immediate preoperative period, but complications and unwanted side effects are described. Due to this side effects, this study will evaluate the the effectiveness of the Virtual Reality Educational Program (RVEP) to reduce the perioperative anxiety in children.

Eligibility Criteria:
Inclusion Criteria:

* Children between 3 and 12 years old.
* Elective surgical intervention.
* ASA I-II (classification of the American Society of Anesthesiologists).
* Surgical complexity grade I-II according to National Institute for Clinical Excellence of the NHS.
* General anesthesia.
* Spanish or Catalan speaking families.
* Understanding the study and signing the informed consent of the study by parents or legal guardians.

Exclusion Criteria:

* Patients suffering from psychiatric or mental illness, psychomotor retardation, blindness or deafness.
* Denial of parents / legal guardians and / or children.
* Ambulatory surgery.
* Surgical intervention of the child the year before the current one.
An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain

The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino participants with osteoarthritis (disorder which is seen mostly in older persons in which the joints become painful and stiff) and chronic (lasting a long time) low back pain.

This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded") single-arm and prospective study (study following participants forward in time) of fentanyl in participants with osteoarthritis and Chronic low back pain with moderate (medium level of seriousness) and severe (very serious, life threatening) pain levels. Participants will be treated with fentanyl transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) starting with 12.5 microgram (mcg) dose of fentanyl. The dose will be increased on Day 3, if needed, by 12.5 mcg. Dose adjustments will be done every 3 days. Maximum of 50 mcg dose of fentanyl will be allowed. Participants will be evaluated for pain levels and quality of life using Brief pain inventory (BPI) score and Clinical global impression-severity (CGI-S) score. Tramadol 50 milligram tablet at a maximum of 6 tablets per day will be used as supplemental doses of analgesic (drug used to control pain). Participants' safety will be monitored through out the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with osteoarthritis and chronic low back pain
* 3 months of persistent moderate to severe pain levels
* More than 3 times a week frequency or daily moderate to severe pain
* Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical pain scale) Exclusion Criteria
* History of allergy to fentanyl transdermal patch or its components and history of illicit drug use for the past 3 months
* Active skin disease preventing application of the transdermal system
* Chronic pulmonary disease (lung disorder)
* Participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention
* Pregnant and breastfeeding mothers
Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'

This is a prospective, observational, non-inferior study in ESRF patients stable on Eprex who are switched to a Biosimilar Epoetin Alfa. Study plans to recrut 44 patients. Following recruitment, a baseline data collection of full routine laboratory test before switch to Binocrit.Primary endpoint is Mean change in haemoglobin levels at 12 weeks and Secondary endpoint is Mean change in haemoglobin levels at 6 weeks Safety endpoint will be Adverse drug reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and Week 12 will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate. Changes in continuous variables over time were evaluated using repeated-measures analysis of variance. Patients with iron-deficiency (ferritin \<100 ng/ml or transferrin saturation \<20%) will be analysed separately

Anaemia in CKD is associated with reduced quality of life and increased cardiovascular disease, hospitalizations, cognitive impairment, and mortality. Correcting anaemia is considered an important part of slowing or even stopping the progression of CKD. Recombinant human erythropoietins (EPO) such as epoetin alfa are erythropoiesis-stimulating agents (ESAs) that are important treatment options. The ESA that is currently used in the hospital is Eprex®, a recombinant human EPO epoetin alfa which will soon be replaced by Binocrit®, a biosimilar ESA approved by the European Medicines Agency (EMA). We want to see whether maintenance of haemoglobin in stable ESRF patients would be affected by this switch in real life practice in the Malaysian population.

This is a prospective, observational, non-inferiority study in ESRF patients stable on Eprex who are switched to a Bio similar Epoetin Alfa .

Study population will be 44 End stage renal failure patients from Penang and Seberang Jaya hospital.Following recruitment, a baseline data collection of full routine laboratory test before switch to a Bio similar Epoetin Alfa .Primary endpoint is Mean change in haemoglobin levels at 6 weeks and Secondary endpoint is Mean change in haemoglobin levels at 12 weeks Safety endpoint will be Adverse drug reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and Week 12 will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate. Changes in continuous variables over time were evaluated using repeated-measures analysis of variance. Patients with iron-deficiency (ferritin \<100 ng/ml or transferrin saturation \<20%) will be analysed separately

Eligibility Criteria:
Inclusion Criteria:

1. End Stage Renal Failure (ESRF) patients on 3x per week HD for at least 6 months who are planned for conversion to Binocrit
2. Stable dose of Eprex and iron for at least 3 months
3. No active bleeding

Exclusion Criteria:

1. Allergy to erythropoietin
2. Bone marrow disorder
3. Acute/chronic bleeding
4. Acute illness requiring hospitalization within the last 3 months
Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection

Reintubation is an adverse postoperative complication in patients with Type A aortic dissection (AAD) that correlates to poor outcomes. This study aims to analyze the risk factors associated with reintubation and to create a fully automated score model to predict the incidence of reintubation. A total of 861 patients diagnosed with AAD and undergoing surgical procedures in a single institution between January 2018 and October 2023 were selected in wuhan Union Hospital. Preoperative and postoperative informmation was used for seeking risk factors and build prediction model for postoperative reintubation. Finally, 5 risk factors wasidentified and a nomogram was established for predicting postoperative reintubation in patients with AAD.


Eligibility Criteria:
Inclusion Criteria:

(1) patients diagnosed with AAD admitted for open surgery; (2) aged 18 years or older.

Exclusion Criteria:

(1) patients deceased during or within 24 hours after surgery; (2) patients with preoperative intubation.