cyrilzakka/clinical-trials huggingface dataset:
Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica

Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Between 40 and 80 years of age, inclusive.
* Body weight \> 50 kg and BMI between 18 and 32 kg/m2, inclusive.
* Able to give informed consent.
* Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee.
* Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee.
* Karolinska Sleep Scale (KSS) score of \<=5.
* Other criteria apply.

Exclusion Criteria:

* Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals.
* Pregnant or lactating or considered at risk of pregnancy.
* Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation.
* Impaired liver function (e.g., alanine aminotransferase \[ALT\] ≥2 times the upper limit of normal \[ULN\] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure.
* Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.
* History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia.
* Other criteria apply.
Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels

The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ER+ breast cancer
* Have taken tamoxifen daily for at least 2 months

Exclusion Criteria:

* Have not taken tamoxifen daily for at least 2 months
Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

Cardiac electrical mapping is an important tool that allows doctors to study the electrical activity of the heart in detail. Electrical mapping systems used in clinical practice are time consuming, invasive and very costly. Ultra-high frequency electrocardiography is a novel non-invasive cardiac mapping system. Ultra-high frequency electrocardiography (UHF-ECG) can be performed in 10-15 minutes without any risk or discomfort to patients.

The aim of this study is to refine this mapping system, verify it against invasive mapping and develop software to bring this novel system into routine clinical use including predicting which patients will respond to cardiac resynchronisation therapy.

This is a single centre laboratory study aiming to utilise ultra-high frequency electrocardiography to construct cardiac electrical activation maps.

All participants will attend for an UHF-ECG. This involves placing standard electrocardiography electrodes (up to 48) followed by electrocardiography recording using the UHF-ECG machine for 10-15 minutes.

Participants undergoing a clinically indicated VT ablation procedure will their UHF-ECG done before the procedure at a separate time. The ablation procedure itself will proceed as standard with no alternation whatsoever in study participants and no invasive measurements will be undertaken during the procedure. After the procedure is complete the 3D electrical maps collected to guide VT ablation will be analyzed and used for the study. The invasive maps will be compared with the non-invasive maps obtained using UHF-EGC.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \> 18 years)
* Able to give consent
* Some patients will be recruited from those listed for a clinically indicated VT ablation
* Patient subgroups as follows; 60 participants with LBBB undergoing a clinically indicated VT ablation , 20 participants with normal 12 lead ECG and normal left ventricular function assessed using standard echocardiography, 20 participants with right bundle branch block morphology on 12 lead ECG, 40 participants with non-specific conduction delay on 12 lead ECG, 60 participants with left bundle branch block morphology on 12 lead ECG and 20 participants who developed left bundle branch block morphology on 12 lead ECG after undergoing aortic valve replacement

Exclusion Criteria:

* Unable to give consent
* Children (age \< 18 years)
The Effect of Psychoeducation Focused on Reducing Internalized Stigma

In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma.

The group most exposed to stigma among mental illnesses is individuals diagnosed with schizophrenia. These individuals avoid treatment due to fear of stigma, which creates a significant obstacle to ensuring their well-being. Internalization of stigma causes feelings of loneliness, anger, helplessness, deterioration in quality of life, and decrease in self-esteem, while at the same time creating a significant barrier to treatment compliance. Compliance problems with treatment: It causes impairments in functionality, relapses and exacerbations, repeated hospitalizations, adverse effects on quality of life and increased mortality rates. The fact that many patients who receive only medical treatment in the treatment of schizophrenia develop negative attitudes towards drug use due to drug side effects and recurrence of disease symptoms reveals that psychosocial approaches should also be given importance in addition to medical treatment. As a result, it is thought that internalized stigma is a significant obstacle to treatment compliance and practices implemented to reduce internalized stigma are effective in increasing treatment compliance.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research,
* Diagnosed with schizophrenia according to DSM-V TR diagnostic criteria,
* Over 18 years old,
* Being in remission for 2 months,
* At least primary school graduate,
* Residing in Edirne city center and its districts,
* Individuals without hearing or understanding problems.

Exclusion Criteria:

* Not meeting the inclusion criteria,
* Having a diagnosis of dementia or other organic mental disorder as an additional diagnosis,
* Individuals with a history of substance abuse (other than nicotine).
Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.

This is an experimental study without drug and device, non-profit, single-center.

The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank.


Eligibility Criteria:
Cancer patients

Inclusion criteria:

* Age\> 18 years.
* Solid tumor diagnosis \[I, II, III, IV stage,\].
* Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
* Signed informed consent.

Exclusion criteria

* Age \< 18 years.
* Absence of signed informed consent.

Elderly subjects

Inclusion criteria:

* Age\> 70 years.
* Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
* Signed informed consent.

Exclusion criteria

* Age \< 70 years.
* Absence of signed informed consent.
Potential Impact of the Use of the Application VentilO

Mechanical ventilation is a vital support associated with the treatment of patients with acute respiratory failure and in other indications such as surgery under general anesthesia, coma or shock. Optimization of settings during mechanical ventilation and implementation of protective ventilation help to avoid ventilation-induced injury, ensure adequate oxygenation and maintain adequate carbon dioxide concentration to avoid respiratory acidosis or alkalosis.

Similarly, there is also no clear recommendation, to our knowledge, for the initial setting of the respiratory rate. Therefore, initial settings are not always adequate and in the literature the frequency of respiratory acidosis is very high, reaching about half of the patients receiving mechanical ventilation.

VentilO, is an application that is available on smart phones. This educational application provides clinicians with initial settings and optimization of these settings based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations and the anatomical and instrumental dead space of patients.

The purpose of our study is to:

1. Assess whether ventilatory settings after intubation are appropriate.
2. To compare the ventilatory adjustments made by clinicians with those proposed by the VentilO appalication.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> or = 18 years old)
* New endotracheal intubation

Exclusion Criteria:

* Absence of arterial (or capillary) gas within two hours of intubation
* Absence of patient sizes available throughout the medical record
Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer

Exocrine pancreatic insufficiency (EPI) is a condition where the pancreas does not have enough pancreatic enzymes to break down food. Some symptoms of EPI are frequent gas/bloating, unexplained stomach pains, frequent diarrhea, and foul-smelling, greasy stools. The purpose of this study is to see how effective CREON is for treating symptoms of EPI due to causes other than cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy (PY), or pancreatic cancer (PC).

CREON (Pancrelipase) is an approved drug used to treat people who cannot digest food normally due to their pancreas not making enough enzymes. Adult participants with a diagnosis of EPI due to causes other than CF, CP, PY, or PC will be enrolled. Around 50 participants will be enrolled in approximately 20 sites in the United States.

Participants will receive oral CREON capsules with each meal and snack beginning at Day 1 for 27 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or a clinic. Participants will need to be confined for 2 separate periods of 6 to 8 days each to measure Co-efficient of Fat Absorption (during screening and after enrollment). The effect of the treatment will be checked by medical assessments, blood and stool tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of exocrine pancreatic insufficiency (EPI).
* Participants who are on pancreatic enzyme replacement therapy (PERT) at the time of consent must have a clinical diagnosis of EPI by their physician.

Exclusion Criteria:

* History of cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, or fibrosing colonopathy.
MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus

This Phase III clinical trial will examine the efficacy, safety, and tolerability of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Japanese Patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus
Reliability and Validity of the Turkish Version of the Multiple Sclerosis Knowledge Questionnaire

Multiple Sclerosis Knowledge Questionnaire (MSKQ) is a 25-item self administered questionnaire assessing a patient's level of knowledge regarding multiple sclerosis (MS). Turkish translation of the questionnaire was prepared and participants in the annual patient education seminar in the investigators' university hospital were asked to answer these questions before and after the seminar.Their results were analysed to assess their level of knowledge about their disease.

Multiple sclerosis knowledge questionnaire was developed in Italy (1) and was reported to be useful in measuring patients' level of knowledge about their disease. The English version of the questionnaire was translated into Turkish by three physicians than back translated into English by two separate linguists. Initially 5 MS patients were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having MS and who attended the annual MS patient education seminar were enrolled into the study. They answered the questions twice, before and after the seminar. Their answers were analysed to measure their level of knowledge about their disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having Multiple Sclerosis
* Attends the annual patient education seminar at the investigators' university hospital
* Older than 18 years of age
* Can read and write

Exclusion Criteria:

* Does not accept to answer the questionnaire
* Unable to answer the questions due to a cognitive impairment
Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function

The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories:

  1. Severe renal impairment: estimated creatinine clearance (CrCl) \<30 ml/min, but not requiring dialysis
  2. End-stage renal disease: requiring hemodialysis
  3. Normal renal function: estimated CrCl ≥90 ml/min
* Documented evidence of symptomatic MM, either newly diagnosed or relapsed/refractory
* Prior Lenalidomide exposure is permitted only if the subject did not discontinue Lenalidomide due to a Grade ≥3 related Adverse Event (AE)

Exclusion Criteria:

* Monoclonal Gammopathy of Undetermined Significance (MGUS), Waldenstrom's macroglobulinemia, or smoldering myeloma
* Active plasma cell leukemia
* All adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved
* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Acute renal failure
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on MASLD and assessment of resolution of liver fibroinflammation. Blood tests will also determine how long it takes the body to eliminate LY3849891. This is a 2-part study and may last up to 32 weeks for each participant and may include 12 visits in parts A and B.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a body mass index (BMI) within the range greater than or equal to (≥) 25 and less than (\<) 50 kilogram per square meter (kg/m²) inclusive
* Participants must have liver fat content ≥10% in Part A and ≥8% for Part B as determined by MRI-PDFF
* Participants must be carriers of the PNPLA3 I148M allele
* Participants with or without type 2 diabetes mellitus (T2DM)

  o For participants with T2DM, hemoglobin A1c (HbA1c) \<8% in Part A and \<9% in Part B
* Male participants agree to use an effective method of contraception for the duration of the study and for 90 days after the last dose of study intervention
* Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or those who are postmenopausal

Exclusion Criteria:

* Participants must not have known or suspected alcohol abuse (\>14 units/week for women and \>21 units/week for men) or active substance abuse
* Participants must not have evidence of cirrhosis or other forms of liver disease
* Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
* Participants must not have active cancer within the last 5 years
* Participants must not have uncontrolled high blood pressure
* Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<60 milliliter per minute per 1.73 square meter (ml/min/1.73m²)
* Participants must not have a diagnosis of type 1 diabetes
* Participants must not have a contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve) or other contraindications for MRI
Musculoskeletal Ultrasound with Elastography in the Evaluation of Muscle State in Rheumatoid Arthritis Patients

Evaluation of muscle state in rheumatoid arthritis patients. Application of elastography in the detection of muscle stiffness in rheumatoid arthritis

Rheumatoid arthritis is a chronic debilitating disease. Muscle weakness is a common symptom in patients with rheumatoid arthritis (RA). From a metabolic perspective, muscle mass is determined by the balance between protein synthesis and degradation. People with RA note tenderness, stiffness, and pain in affected muscles.

In RA, chronic inflammation is a primary driver of muscle weakness. Persistent synovitis leads to the release of pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6), which contribute to muscle atrophy and dysfunction. Joint damage and pain further limit physical activity, exacerbating muscle wasting through disuse atrophy. Additionally, the systemic inflammation associated with RA can lead to metabolic disturbances, including insulin resistance, which negatively impacts muscle protein synthesis and overall muscle health.

RA can cause a 25% to 70% reduction in muscular strength, typically caused by decreased skeletal muscle mass, ,Reduced muscle strength is usually considered to be a result of decreased muscle mass due to disuse atrophy. Rheumatoid cachexia, a term used in RA, is defined as a loss of skeletal muscle mass and with no, or little weight loss in fat mass Muscle weakness not only reduces the quality of life for the affected patients, but since patients\&amp;#39; ability to work decreases it will also dramatically increase the burden on society (e.g. increased costs for long-term sick leave). Thus, RA severely affects both the individual and the society Given the complexity of muscle affection in RA , accurate assessment is essential for effective management. Conventional clinical methods, such as manual muscle testing and grip strength measurements, provide limited information on the underlying causes of muscle weakness. Advanced imaging techniques, such as conventional ultrasound (US) and shear wave elastography (SWE), offer a more comprehensive evaluation by providing detailed information on muscle morphology and stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18:70 years
* RA patients with positive RF And Anti ccp

Exclusion Criteria:

* History of injury or operation of the lower limb and upper limbs .
* History or clinical signs of neuromuscular disorders.
* Patients on drugs causing myopathy or myositis
* History of chronic diseases : kidney and liver disease
* Diabetic patients .
Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety parameters will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* LDL-C\>130 or \>160 mg/dL (depending on the total risk according to the most recent recommendations25).
* no previous hypolipidemic medication
* ability to provide Informed Consent.

Exclusion Criteria:

* pregnancy or lactation
* myocardial infarction or unstable angina within the past 6 months
* heart failure NYHA class III-IV
* renal disease (SCr\>3 mg/dL or proteinuria\>3g/d)
* liver disease
* history of malignancy
* history of drug or alcohol abuse
* treatment with corticosteroids
* any other condition with poor prognosis
* inability to provide Informed Consent.