cyrilzakka/clinical-trials huggingface dataset:
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis

To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg, a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors. Safety was also to be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are confirmed to have 1-5 metastatic brain tumor by the latest contrast-enhanced cerebral CT or contrast-enhanced cerebral MRI, and the lesion(s) have not been treated by surgery or by stereotactic radiosurgery.

Exclusion Criteria:

* Patients who are scheduled to receive another contrast medium for MRI (except for oral agents) or iodine contrast medium (except for oral agents), or to undergo surgical procedures during the period from the day before administration of Magnevist (SH L 451A) to examination of safety on the following day.
* Patients who underwent or are scheduled to undergo radiotherapy during the period from 14 days before administration of Magnevist (SH L 451A) to examination of safety on the following day.
* Patients who were treated or are scheduled to be treated with anti-cancer agents (except for treatment only by the oral agents of the fixed dose continuously from 28 days or more before administration of Magnevist (SH L 451A)) during the period from 28 days before administration of Magnevist (SH L 451A) to examination of safety on the following day.
Electrophysiologic Measures of Treatment Response in Alzheimer Disease

The main purpose of this study is to determine the electrophysiological effects of cholinergic therapy (cholinesterase inhibitors and transdermal nicotine) in Alzheimer disease. The attempt will be to locate electrophysiological markers and predictors of cognitive and clinical treatment response.


Eligibility Criteria:
Patients diagnosed with mild to moderate probable Alzheimer's disease (mini-mental state exam scores between 15-27), and normal controls (age generally between 60-85). Subjects must either be planning to start daily cholinesterase therapy (e.g. Aricept, Exelon) or willing to try a transdermal nicotine patch for two 8 hour periods.
Screening for the Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR FAP)

An International, multicenter, epidemiological observational study investigating the prevalence of Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP) in participants with small fiber polyneuropathy of no obvious etiology.

Transthyretin-related Familial Amyloid Polyneuropathy (TTR-FAP) is an autosomal dominant, progressive neurodegenerative disease, with fatal outcome occurring within ten years after onset. Familial amyloid polyneuropathy (FAP) associated with mutations in the transthyretin (TTR) gene is the most common form of genetic amyloidosis. It accounts several thousand cases worldwide, with Val30Met mutation identified in most patients and with endemic foci in Portugal, Sweden and Japan.

TTR FAP is caused by the systemic deposition of amyloidogenic variants of the transthyretin protein ((Ttr) in the extra-cellular space of tissues and result in disruption of organ function.The typical presentation of TTR-FAP is a progressive sensory-motor polyneuropathy, which usually begins with loss of thermal and pain sensation in the feet, slowly ascends up the limbs and is associated with variable autonomic disturbances and extra-neurological manifestations (especially a cardiomyopathy).

The goal of the TRAP2.1 Study is to investigate the prevalence of Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP) in a cohort of 500 subjects with small fiber polyneuropathy of no obvious etiology, based on the subject's clinical presentation.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the participant
* The participant is aged between 18 and 85 years of age
* The participant is diagnosed with small fiber polyneuropathy of no obvious etiology
* The participant has no diagnosis of alcoholism, according to International Guidelines
* The participant has not undergone chemotherapy for carcinoma

Exclusion Criteria:

* Inability to provide informed consent
* The participant is younger than 18 years or older than 85 years of age
* The etiology of the small fiber polyneuropathy is clearly determined
* The participant has a diagnosis of alcoholism, according to International Guidelines
* The participant has undergone chemotherapy for carcinoma
Short-Term Music Training and Auditory Processing in Older Adults

Most adults experience some degree of hearing loss by age 60. Hearing aids can improve some aspects of peripheral hearing but the loss of the ability to clearly perceive speech in noisy environments remains to be a significant deficit and often reduces life quality in older adults. Long-term music training has been shown to enhance auditory processing and specifically benefit speech-in-noise perception. It is not clear however whether short-term participation in a musically engaged activity can benefit such abilities in older adults. The proposed study aims to investigate whether short-term participation in a weekly community choir can improve speech in noise perception and its neural substrates as measured by sensory auditory evoked potentials (ERPs) to speech stimuli in older adults with mild to moderate subjective hearing loss. Sixty participants, ages 50-65, will be recruited to partake in this study and will be randomly assigned to two groups: participants in the experimental group will join a weekly remote choir on an on-line platform (Zoom), for ten weeks, directed by a professionally trained conductor from USC Department of Choral Music. The group practice will be accompanied by individual singing lessons (online or CDs) for home practice. Participants in the control group will be provided with weekly remote mindfulness lessons also on an on-line platform. All participants will be assessed remotely pre and post intervention, with behavioral measures of speech in noise perception and probes assessing emotional well-being and life satisfaction. Changes in auditory measures and their neural correlates and overall quality of life will be compared between the groups. The findings from this study can provide preliminary data to support a larger study on the impact of music engagement in improving the lives of older adults.


Eligibility Criteria:
Inclusion Criteria:

* Native English speaker with experience of subjective hearing loss;
* Normal IQs (standard score of \>85) as measured by the two-subtest Abbreviated Wechsler's Adult Scale of Intelligence.

Exclusion Criteria:

* Use of prescribed hearing aids;
* Sever hearing loss (thresholds of 60 and 95 dB)
* Current diagnosis of neurological or psychiatric disorders
* Impaired cognitive function (all participants will be screened with the Montreal Cognitive Assessment Battery)
Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars

The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.


Eligibility Criteria:
Inclusion Criteria:

1. Systematically healthy patient (ASA I,II).
2. Age between 20 and 55 years
3. Male or female.
4. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with or without apical periodontitis.
5. Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.
3. Teeth with:

   * Immature roots
   * Vital pulp tissues.
   * Association with swelling.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III.
   * Previously accessed or endodontically treated
   * Deep periodontal pockets more than 4 mm
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
4. Patients who could not interpret the NRS.
5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
Functional Evaluation of Two Types of Totally Implanted Venous Ports

Totally implanted venous access ports allow a safe delivery of medication, mainly chemotherapy, but are also used for blood sampling. This last procedure is not always successful, as it appeared from a nurse's survey in different hospitals in Flanders, including the University Hospitals in Leuven, Belgium. In 3 to 29 percent of the attempts, blood withdrawal is impaired or not possible, as an intermittent or permanent fact. This is in line with international literature data where difficulty in blood draw was noted in 6 to 26% of port accessions. Partial or total occlusion leads to discomfort for the patient, delay in therapy, higher costs and extra nursing time.

A new port system with a tangential outlet (Vortex port) was designed and according to the manufacturer, this shape will allow to cleanse the entire reservoir of the port more efficiently and avoid the formation of precipitates of medication or blood that could lead to an obstruction of the device. These precipitates are also regarded as a potential risk factor for infection.

However, only one previously published small randomised study addressed the value of the Vortex port when compared to conventional access devices: Stevens et al. were able to show a reduction in obstruction incidence from 26% to 7% with the use of the Vortex port. The incidence of blood withdrawal problems in our experience with conventional ports in University hospitals Leuven was 8% thus lower than that reported by Stevens, but this remains the most frequent problem faced by care providers and patients.

With this study, the investigators aim to compare the performance of the tangential outlet ports and that of a "conventional" port in order to assess an eventual functional difference.


Eligibility Criteria:
Inclusion Criteria:

* request of a standard size totally implanted venous port
* patent superior vena cava
* normal clotting tests (PT\>40% and platelet count \>40000/mm3)

Exclusion Criteria:

* unable to provide written informed consent
Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy

This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.

This project is a multicenter prospective study. The selected case population was given the oral antiepileptic drug perampanel for 12 months, and the seizure control (complete control, markedly effective, effective, ineffective, worsening), EEG changes (normal, Effective, ineffective), and adverse reactions were analyzed, so as to provide a basis for perampanel monotherapy in children with focal epilepsy.

Eligibility Criteria:
Inclusion Criteria:

(1) Clinical diagnosis of focal epilepsy; (2) Take anti-epileptic drugs as prescribed by your doctor; (3) Epilepsy patients diagnosed with focal epilepsy with or without generalized seizures, and Monitoring for ≥12 months; (4) Newly diagnosed epilepsy patients, or only taking 1-2 other AEDs, without regular antiepileptic treatment, the efficacy is not good, after using perampanel, gradually stop AEDs for 8 weeks. For perampanel monotherapy; (5) the number of seizures ≥ 1 in the first 3 months of enrollment.

Exclusion Criteria:

(1) syncope (2) Pseudo-seizure(3)transient ischemic attack
Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

The clinical success of percutaneous transhepatic biliary drainage procedures (PTBDs) is usually measured by the the decrease of the serum bilirubin value. However, the bilirubin value can be biased by other disease conditions. Furthermore, the time course of the decrease of the bilirubin value after technically successful PTBD is not well known. Serum gamma-glutamyl transferase (GGT), a liver enzyme which is typically elevated in cholestatic liver diseases, might be a good alternative to bilirubin as an indicator for the clinical success of PTBDs. The aim of this study is to analyse the bilirubin level and the GGT level in patients with technically successful PTBD.

The medical records of adult patients who have received a technically successful PTBD will be screened sytematically in terms of bilirubin and GGT values in the follow up of 4 weeks after the intervention. Bilirubin and GGT values have been routinely examinated every 1 to 3 days. PTBD comprises external plastic endoprosthesis, combined external and internal endoprosthesis and primary metal stent insertion. The respective three procedures are considered separately. As PTBD is a rare intervention which is used after failed or impossible endoscopic retrograde cholangiopancreaticography (ERCP) medical records will be screened from 2002 to 2022 (20 years). It is expected that for example a decrease of GGT after three days might indicate a successful procedure. This in turn might has an impact on the early demission of the patient. On the other side, the precise definition of successful PTBD by bilirubin or GGT value might help to make this procedure better comparable to other alternative biliary drainage procedures such as endoscopic ultrasound-guided biliary drainage.

Eligibility Criteria:
Inclusion Criteria:

* technically successful PTBD

Exclusion Criteria:

* technically not successful PTBD
Clinical Trial to Evaluate the Efficacy and the Safety of Antihypertensive Tablets

The purpose of this study is to determine the optimal dosage of the clinical trial which is evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.

Evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women (Age 18-75 years)
2. Uncomplicated essential hypertension: Clinic sitting SiDBP between 90 and 109 mmHg after 2 week placebo run-in period

Exclusion Criteria:

1. Secondary hypertension
2. History and/or signs of cardiovascular complications (eg; myocardial infarction, unstable angina)
3. Pregnancy or lactation
4. Contraindications to the antihypertensive drugs to be used during the treatment period
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age

This study will evaluate the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF subjects 12 to less than (\<) 24 months of age.


Eligibility Criteria:
Key Inclusion Criteria:

Participants who have at least 1 F508del mutation in the CF transmembrane conductance regulator (CFTR) gene or another ELX/TEZ/IVA-responsive CFTR mutation

Key Exclusion Criteria:

History of any illness or any clinical condition that, in the opinion of the investigator, might either confound the results of the study or pose an additional risk in administering study drug(s) to the participant

Other protocol defined Inclusion/Exclusion criteria may apply.
A Nomogram Predicting the Risk of High-dose Transfusion in Non-cardiac Surgery

This retrospective study was designed to develop a preoperative nomogram, validated both internally and externally, to supply an individual and precise tool for predicting the probability that patients will require perioperative transfusion therapy.

Perioperative red blood cells (RBCs) transfusion is a necessary guarantee for surgical surgery and one of the indispensable means in modern medical treatment. In recent years, with the continuous improvement of medical standards, various major and complex surgeries have been carried out. The total number of patients receiving surgical treatment increased year by year, and the demand for surgical blood has also increased rapidly. Although unpaid blood donation has been vigorously advocated in recent years, the supply of blood products are still difficult to meet the growing demand for clinical blood. RBCs transfusion is often associated with unavoidable complications such as anaphylaxis and transfusion-related acute lung injury, which may lead to delayed recovery, increased hospital stay and medical costs, and result in serious adverse effects and even death.

Hemorrhage is a common complication of surgery. The effect of blood transfusion treatment and the patient's recovery process will be affected by the amount of blood transfused during the perioperative period. Similarly, blood products that are prepared in advance for surgery often remains unused perioperatively, leading to the waste of valuable blood resources and an increase in hospital expenses. Hemorrhage is one of the leading causes of death in various clinical situations, such as severe trauma, heart surgery, and traffic accidents.Timely and effective high-dose transfusion is directly related to life and death. However, high-dose transfusion may also lead to dilution coagulopathy, increased risk of bleeding, and imbalance in the internal environment.

In brief, there is an urgent requirement for a systematic, evidence-driven tool to comprehensively weigh the risks and benefits of high-dose RBCs transfusion in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing non-cardiac surgery during hospitalization.
* Patients receiving allogeneic RBCs transfusion within 24 hours during and after surgery.

Exclusion Criteria:

* Age under 15 years.
* Patients with incomplete clinical data.
Role of 90K/Mac-2 BP as an Indicator of Early Response to Infliximab Therapy in IBD Patients

The aim of this study is to analyze the relationship between 90K serum levels measured at baseline and after induction in IBD patient undergoing infliximab therapy, in order to clarify the role of serum 90K as an adjuvant biomarker for IBD patients in the active phase. Furthermore, the study aims to evaluate the clinical usefulness of this new biomarker in the management of IBD patients undergoing infliximab therapy.

Type of the Study: The current work will be single cohort study.

Study settings: IBD outpatient clinic at Rajhy gastroenterology and Hepatology Hospital at Assiut University Hospital.

Study Duration: June 2023- June 2024 Study population: Participants will be 50 patients were recently diagnosed with Inflammatory Bowel Disease (IBD), Crohn's disease (CD) and Ulcerative Colitis (UC), undergoing the anti-TNF drug infliximab. Infliximab therapy will be administered intravenously initially at a dose of 5 mg/kg/ dose, and then after two and six weeks after the first dose, and fulfill the following inclusion criteria

Inclusion Criteria:

1. Adult male and female patients aged 18-60 years old.
2. IBD patients, diagnosis was confirmed by biopsy and histopathology, scheduled for treatment with anti-TNF therapy, Infliximab, and no previous treatment with anti-TNF therapy.

Exclusion Criteria:

1. Comorbidities (assessed with the Charlson Comorbidity Index).
2. Ongoing immunosuppressive or immunomodulatory therapy.
3. A malignant neoplasm in the last 10 years.
4. Pregnancy or breast feeding.
5. The need for artificial nutrition.

Study assay:

1. History taking and clinical examination, including the time and duration of diagnosis, manifestations of disease severity, and previous treatment received.
2. Laboratory investigations:

A. Routine investigations: such as complete blood count, liver function test (including serum albumin, liver enzymes, bilirubin), kidney function test (serum urea and creatinine, GFR), ESR and C - reactive protein.

B. The concentration of serum 90K glycoprotein is determined by ELISA assay, according to the manufacturer's instruction. Serum levels will be withdrawn before the first dose and after the third dose.

Statistical Tests:

Statistical tests will be performed with frequency and cross tabulations for categorical variables. Data will be reported as Mean+/- Standard Deviation (M +/- SD) for all numerical variables.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female patients aged 18-60 years old.
2. IBD patients, diagnosis was confirmed by biopsy and histopathology, scheduled for treatment with anti-TNF therapy, Infliximab, and no previous treatment with anti-TNF therapy.

Exclusion Criteria:

* 1. Comorbidities (assessed with the Charlson Comorbidity Index). 2. Ongoing immunosuppressive or immunomodulatory therapy. 3. A malignant neoplasm in the last 10 years. 4. Pregnancy or breast feeding. 5. The need for artificial nutrition.
Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease

The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. The aim of Heart \& Mind Trial is (I) to determine the type of anxiety in cardiac patients and (ii) to investigate the effect of individual cognitive behavioural therapeutic intervention to reduce anxiety in patients with cardiac disease and anxiety compared to usual care.

The Heart \& Mind Trial is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including four university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone.

The intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy.

The intervention consists of three steps: (1) screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with (CBT) training, plus usual care or usual care alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years
* Diagnosed with cardiac disease
* Speak and understand Danish
* Score ≥8 on the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
* HADS-A score must exceed the HADS-D score
* Gives written informed consent.