cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia

Chronic myeloid leukemia (CML) consists of 3 clinical stages including chronic phase, accelerated phase and blast crisis. Patients may only survive for few more days to weeks once the disease progresses to blast crisis, even though they might have been stable for several years in the chronic phase. The standard treatment, continuous use of tyrosine kinase inhibitors (TKIs), improves long-term survival, and even may help patients achieve complete remission. Four TKIs are reimbursed by National Health Insurance in Taiwan. Among them, imatinib, nilotinib as well as dasatinib, and ponatinib are the first, second and third generations of TKIs, respectively. Many factors influence the disease control of CML, such as TKI type, genetic mutation and medication adherence. Only 69% of patients followed their physicians' recommendations in a local survey. The medication adherence of TKIs was compromised based on several clinical studies domestically and worldwide due to the slow progression in the chronic phase. Patients might hold or decrease the dose of TKIs on their own when they suffer side effects. Furthermore, the significant intra-subject variations of TKI plasma concentration and drug-drug and drug-food interactions which alter the metabolism of TKIs may lessen therapeutic effect and patient safety. Therefore, this study aims to develop and validate analytic methods of imatinib, dasatinib, nilotinib and ponatinib plasma concentrations. The investigators plan to build the pharmacokinetic models of these 4 TKIs and analyze the impacts of meals, adherence, hepatic enzyme inhibitors and inducers, antacids, proton pump inhibitors and H2 blockers, etc. Adverse drug reactions and treatment outcomes will be evaluated to determine the availability and feasibility of therapeutic drug monitoring of TKIs as part of routine service in pharmacist-led clinics.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥ 20 year-old)
2. Patients who meet the above criteria and have already initiated or are going to receive imatinib, dasatinib, nilotinib, or ponatinib treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from September 2022 to December 2025

Exclusion Criteria:

1. Patients who are unable to cooperate with blood drawing
2. Patients who have not submit the informed consent
Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.

Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.

Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Age 1-14 years both male and female who require mechanical ventilation
2. Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
3. Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours

Exclusion Criteria:

1. Septic shock and/or multi-organ failure.
2. Hemodynamically instability and requires inotropes.
3. Severe intracranial or spinal trauma with high intracranial pressure
4. Liver failure
5. Acute or chronic renal failure.
6. Glasgow Coma Scale (GCS) ≤8
7. Known to have allergy to the study drugs
8. Airway surgery
Role of Music Listening in Gastrointestinal Endoscopy

Gastrointestinal endoscopy is widely acknowledged as the most useful tool for diagnosing and treating gastrointestinal mucosal lesions. It can not only observe the mucosa directly, but also obtain tissue biopsy for pathological diagnosis. Although the importance of gastrointestinal endoscopy has been well understood, there are still a certain proportion of people who are unwilling to undergo it due to the discomfort and anxiety during the procedures. Music is multifunctional, which can alleviate people's depression, anxiety and other negative emotions as well as help to maintain good mental health. Thus, in this study we aim to investigate the role of music listening in gastrointestinal endoscopy in a randomized controlled clinical trial, especially for those patients who plan to undergo therapeutic endoscopic procedures and try to improve the patients' experience.

This is a randomized controlled trial to examine the function of music listening in the procedures of gastrointestinal endoscopy. It was previously reported that music listening may exert beneficial effects for patients who undergo gastrointestinal endoscopy. However, most of the studies did not analyze the effects of the specific music type and listening time in diagnostic and therapeutic gastrointestinal endoscopic procedures, respectively. This study will test whether the specific music type and listening time before gastrointestinal endoscopy could improve patients' experience of the procedure in a randomized controlled trial. The results may help to optimize the routine clinical practice at present.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old patients
* Who agree to participate in the study
* Patients with the indications for gastrointestinal endoscopy

Exclusion Criteria:

* Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
* Severe uncontrolled coagulopathy
* Pregnancy and lactation
The Role of the Thymus in Myasthenia Gravis

Although the association between thymic hyperplasia / thymoma and autoimmune myasthenia gravis has been known for some time, the question of causality remains uncertain. Recent research findings indicate, however, that especially in myasthenia patients with thymomas a non-physiological export of naive CD4 + T-cells can take place by the tumour and this could possibly play an important role in the pathogenesis of myasthenia gravis. The investigators want to analyse the functionality and specificity of t-cells generated in thymomas as well as the effect of thymectomy on the immune system.

On one hand we want to perform a detailed analysis of the T-cells generated in thymomas in terms of their functional capacity and their specificity. We will analyse blood and thymoma tissue of patients with myasthenia gravis with thymona, patients with myasthenia gravis without thymona, and patients with thymona without myasthenia gravis.

Hypothesis: The T-cells which are generated in the thymoma in thymoma-associated myasthenia gravis can be differentiated from T-cells which are generated in normal thymoma tissue with regard to functionality and T-cell receptor specificity. This non-physiological T-cell maturation might be the cause for the formation of auto-antibodies.

On the other hand we want to examine the effects of thymectomy on the immune system in the context of myasthenia gravis. We will analyse blood and thymoma tissue of patients with myasthenia gravis with thymona, patients with myasthenia gravis without thymona, patients with thymona without myasthenia gravis and patients with cardiac, or thyroid surgery.

Hypothesis:

1. Thymectomy in patients with myasthenia gravis leads to a reduced number of auto-reactive, e.g. Acetylcholine receptor (ACh-R)-specific T cells. In contrast, T-cells with other specifities, for example against CMV or tetanus, are not affected.
2. The non-physiological export of thymocytes from thymomas leads to a significant shift in leukocyte populations in peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

* Patients with compelling indications for thymectomy due to thymoma (with or without myasthenia gravis), Or
* Patients with elective indication for thymectomy due to thymoma without myasthenia gravis
* Patients with indication for a heart or thyroid surgery, in which for op-technical reasons, a (partial) resection of the thymus is performed.
* Signed informed consent form
* Age \> 17 Years

Exclusion Criteria:

* Other immunological diseases such as rheumatoid arthritis, multiple sclerosis
Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).

Material and methods: We have enrolled 26 ideopathic carpal tunnel syndrome patients (minimal to moderate according to Padua's classification).Thirteen patients were allocated in sonography approach group( sonography-guided local wrist injection, SAG) and the 13 patients were placed in direct approach group(direct local injection without using sonography, DAG). One , 3 and 6 months later after injection, we performed the outcome measures, including Boston symptom and functional scale, QuickDASH, nerve conduction study and sonography. If the patients receive the second injections, we will follow their treatment outcome by phone regularly at 1,3 and 6 months after first injection. If the patients were referred to surgery, the failures of local injection were considered and we will stop follow up them. After performing all assessment, we will compare the outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* with \>2 following symptoms :

  1. disrupt sleep result in nocturnal paresthesia.
  2. symptoms release by shaking hand.
  3. pain and paresthesia during grasping.
  4. any sensory symptom on first, 2th, 3th and partial 4th fingers.
* symptoms \>1month.
* Padua's classification : minimal, mild, moderate)
* meet one of three diagnosis criteria of carpal tunnel syndrome.

Exclusion Criteria:

* any history can cause periphery nerve disease.
* affected side had fracture or paralysis.
* had accepted operation for carpal tunnel syndrome before.
* pregnant
* wrist or hand sprain, ulnar nerve disease cervical nerve root disease, multiple neuropathy or nerve anastomosis.
* Padua's classification: severe, extreme.
* ultrasonography show space occupying.
* patient taking anticoagulants.
* severe systemic disease.
* wrist's skin or wrist joint has infection.
* can't complete the 6 months' follow up.
* allergy to steroid.
* has cognition disorder.
A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck

This is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven squamous cell carcinoma of the head and neck or squamous cell cancer to the neck from an unknown head and neck primary site, stage I-IV disease which is M0, age greater than 18 years, KPS greater than 70, signed study-specific consent

Exclusion Criteria:

* M1; bilateral N3 disease; primary greater than 10cm; salivary gland disease; life expectancy less than 2 years; prior radiotherapy to the head and neck; no signed study-specific consent form
Allopurinol in Acute Coronary Syndrome

Allopurinol is a drug commonly used to treat gout. However recent studies have shown it has the potential to help improve oxygen supply to heart muscle. In this study the Investigators aim to find out if allopurinol slows down the onset of angina symptoms, as seen by a doctor on a tracing of the heart (ECG- electrocardiogram), for patients who have been diagnosed with heart disease, when exercising on a treadmill. The Investigators are also are trying to figure out the best dose of allopurinol to use and to see how quickly it begins working. To do this the investigators will recruit patients with angina, exercise them on a treadmill after giving different doses of allopurinol and see if there is an improvement in their time to bring on angina symptoms and signs. Patients recruited to this trial will receive three different treatment regimes over a six week period. Each treatment regime will last for one week with a one week rest period between each regime. This will involve up to eleven visits to Ninewells Medical School, Dundee for testing.


Eligibility Criteria:
Inclusion Criteria:

* angiographically documented coronary artery disease,
* a positive exercise tolerance test (ETT)
* a history of symptoms of chronic, stable, effort-induced angina for ≥ 2 months.
* All concomitant antianginal medication will be allowed and continued unchanged during the study.

Exclusion Criteria:

* the inability to do an ETT due to back or leg problems,
* myocardial infarction or acute coronary syndrome ≤ 2 months,
* coronary revascularization (percutaneous or CABG) ≤ 6 months,
* Left Ventricular Ejection Fraction \<45%,
* estimated GFR \<60 ml/min or creatinine \>180 mmol/ml,
* significant valvular pathology,
* already had gout or on allopurinol,
* atrial arrhythmias or ECG abnormalities interfering with ST-segment interpretation,
* previous ventricular arrhythmias on ETT,
* severe hepatic disease
* or on azathioprine, 6 mercaptopurine or warfarin.
* Patients who have participated in any other clinical trial within the previous 30 days will be excluded.
* Patients who are unable to give informed consent will also be excluded from this trial
A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery

This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.

To evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts in real-world clinical settings, medical history and follow-up data from 113 subjects of Dexycu group and 150 subjects of external control group will be prospectively collected in Hainan, China. Additionally, questionnaires will be collected from surgeons on 30 cases to evaluate the difficulty, duration and safety of the Dexycu injector.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to understand and sign the informed consent form and be able to follow the study procedures.
* Male or female subjects over 40 years of age who are scheduled to undergo cataract phacoemulsification surgery combined with intraocular lens implantation.

Exclusion Criteria:

* Known hypersensitivity to dexamethasone or any component of the Dexycu.
* History of intraocular inflammation of any cause in either eye, presence of corneal abnormalities or malnutrition.
* Have high intraocular pressure, with an IOP(intraocular pressure) of \> 21 mmHg in the test eye at screening, regardless of whether receiving anti-glaucoma monotherapy therapy.
* Posterior capsule rupture or lens dislocation, anterior vitreal membrane rupture, vitreous prolapse and intraoperative floppy iris syndrome during cataract surgery.
* Other conditions that the investigator considers inappropriate to participate the study.
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer

The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer

This Phase Ib study will investigate the safety and anti-tumor activity of daily oral doses MEN1611 in combination with Trastuzumab with/without Fulvestrant in female and male patients affected by advanced or metastatic HER2-positive breast cancer. Fulvestrant will be added to the post-menopausal patients with hormone-sensitive disease.

MEN1611 is an investigational drug which blocks a protein called PI3K (phosphoinositide 3-kinase) involved in cancer cells growth. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.

This Phase IB will start with a dose escalation part (Step 1) to identify the MTD of MEN1611 given in combination with Trastuzumab with/without Fulvestrant.

The study will continue with a cohort expansion (Step 2) to investigate the anti-tumor activity of the selected MEN1611 dose level considered to be tolerable by a Safety Review Committee.

Eligibility Criteria:
Main Inclusion Criteria:

* Histologically confirmed invasive adenocarcinoma of the breast
* Known HER2+ breast cancer
* Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample
* \> 2 lines of anti-HER2 based regimens with at least 1 regimen with trastuzumab
* Radiological documented evidence of progressive disease
* Life expectancy ≥ 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Main Exclusion Criteria:

* Previous treatment with PI3K inhibitors
* Brain metastases untreated, unless treated \> 4 weeks and only if clinically stable and not receiving corticosteroids
* History of clinically significant bowel disease
* ≥ grade 2 diarrhoea
* History of significant, uncontrolled, or active cardiovascular disease
* Any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient's safety
* Not controlled diabetes mellitus (glycated haemoglobin \[HbA1c\] \>7%) and fasting plasma glucose \>126 mg/dL
* Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent
Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based

The purpose of this study is to determine whether a multifactorial primary care intervention based on chronic models can improve the level of control and reduce the number of hospital admissions in patients with ischemic heart disease.


Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of IHD of any site (ICD-10 codes from 410 to 414 inclusive.
* signed written informed consent

Exclusion Criteria:

* lack of consent
* immobilized patients
* patients with serious health problems or with a low life expectancy
A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study

The purpose of this study will be to evaluate the safety and tolerability of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).

This will be a multicenter, double-blind, randomized, placebo-controlled study in subjects with mild to moderate Alzheimer's disease. The study will comprise separate single dose ascending (SAD) and multiple dose ascending (MAD) parts designed to allow the MAD part to be initiated while the SAD part is ongoing.

Eligibility Criteria:
Inclusion:

1. Clinical diagnosis of probable mild to moderate Alzheimer's disease (AD) by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association Alzheimer's (NINCDS-ADRDA) criteria.
2. A Mini Mental State Examination (MMSE) score of 16 to 28, inclusive, at Screening. Subjects recruited to the first 2 SAD cohorts should have an MMSE of \> 22.
3. Where symptomatic treatment of Alzheimer's disease (AD) is clinically indicated, subjects must be on stable treatment (e.g., with an anticholinesterase inhibitor \[AChEI\] and/or memantine) for at least 12 weeks prior to the Screening visit.
4. On stable doses of all other prescribed medications for at least 4 weeks prior to the screening visit.

Exclusion:

1. Any neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's disease (AD).
2. Any psychiatric diagnosis or symptoms, e.g hallucinations, major depression, or delusions, that could interfere with assessment of cognition in the subject.
3. History of transient ischemic attack (TIA), stroke, or seizures within 12 months of Screening.
4. Evidence of infection, tumor, stroke or other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain magnetic resonance imaging (MRI) at Screening.
5. Other significant pathological findings on brain MRI at Screening, including but not limited to: more than 3 micro-hemorrhages, single macro-hemorrhage; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations or space occupying lesions.
Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes

Hypothesis:

Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.

Patient will have weekly contact through the Mayo Patient On-line Services to send in their blood glucose readings and to receive recommendations back regarding insulin dose changes. Information will be analyzed regarding the magnitude of change in insulin dosing and in glycemic variability.

Eligibility Criteria:
Inclusion Criteria:

* Adult pregnant women with type 1 diabetes utilizing either an insulin pump or multiple daily injection insulin program to manage their diabetes

Inclusion Criteria:

* Female with type 1 diabetes and pregnancy
* EDD prior to November 15, 2014
* 18 years of age and older
* On insulin pump or multiple daily injection insulin program
* Signed patient consent form

Exclusion Criteria:

* Exclusion Criteria:

  * Female with type 1 diabetes and pregnancy under age 18 or older than age 45
  * Female with type 2 diabetes or gestational diabetes and pregnancy
Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

Herpes Zoster is an infection that affects part of the nervous system caused by Varicella Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often associated with significant pain.

There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms as famciclovir and aciclovir.

This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients with Herpes Zoster.

Study Design

* single blind study, prospective, parallel group, intent to treat trial
* Experiment duration: 7 days
* 2 visits (days 0, and 7)
* Reduction of symptoms
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to understand the study procedures, agree to participate and give written consent.
* Patients with clinical diagnosis of Herpes Zoster;
* Score higher than 4 for at least for 2 symptoms of Herpes Zoster;
* Negative pregnant urine test

Exclusion Criteria:

* Pregnancy or risk of pregnancy.
* Lactation
* Any pathology or past medical condition that can interfere with this protocol.
* Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
* Patients with immunodeficiency and/or immunosuppressive disease;
* Hypersensitivity to components of the formula;
* Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.