cyrilzakka/clinical-trials huggingface dataset:
Detection of Pathogen and Antibiotic Resistance Genes by Targeted Next-Generation Sequencing in ICU Patients.

It is difficult to determine the pathogens in the early stage of infection in critically ill patients, and empirical use of broad-spectrum antibiotics for a long time is often necessary, leading to antibiotics drug resistance. Targeted next generation sequencing (tNGS) can provide faster results for pathogen and related antibiotic resistant diagnosis. But it lacks sufficient clinical evidence. Evidence regarding the clinical diagnostic accuracy and drug resistance is needed to comprehensively evaluate targeted next generation sequencing (tNGS) for diagnosis of patients in ICU who and will be critical to inform national policy.

Infectious diseases are one of the highest mortality and morbidity diseases in humans. Due to the difficulty in identifying the pathogen in the early stage of infection, patients with severe infections often need to empirically use broad-spectrum antimicrobials for a long time. The traditional gold standard of etiological detection - etiological culture, even in sepsis patients, only about 60% of the results are positive. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment.

Metagenomic next generation sequencing (mNGS), which has emerged in recent years, have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but it is expensive and not able to provide related drug resistant genes. Therefore, targeted next generation sequencing (tNGS) has been derived, which is characterized by rapid sequencing and genetic testing for drug resistance.

The purpose of this study is to evaluate the efficacy of etiological diagnosis and provide patients with more accurate treatment.

Eligibility Criteria:
Inclusion Criteria:

* The presence of an infection or clearly excluded the presence of infection.
* Etiological culture and/or metagenomic next-generation sequencing detection of specimens sent for testing.

Exclusion Criteria:

* Suspected infection.
* Participation in other clinical trials in the past 2 months.
Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients

This is a prospective, randomized, open label, parallel,4-month study to explore and evaluate the therapeutic effects of polyethylene glycol loxenatide on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with normal cognitive status or MCI.

This is a prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of polyethylene glycol loxenatide on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with normal cognitive status or MCI inadequately controlled with metformin monotherapy. The control group was treated with Gliclazide. There are 1 principal investigator, 6 sub-investigators and 1 nurse in research centre. The sub-investigators will screen in the outpatient and inpatient departments to enroll 58 patients (29 patients for each arm) totally with the inclusion and exclusion criteria in 9 months. The patients will be randomized at a 1:1 ratio into loxenatide and Gliclazide treatment group with a computer-generated random order. All patients will also continue on their existing dose and regimen of metformin throughout the study. At the baseline, clinical information collection, 100g-steamed bread meal test, biochemical measurement, body composition analysis, cognitive assessment, olfactory test and functional magnetic resonance imaging(fMRI) scan will be conducted for all patients. During the treatment period, visits at 4-week intervals will be performed to evaluate the safety of drugs and adjust the dose of metformin if hypoglycaemia occurs; meanwhile, fasting and 2-hour postprandial plasma glucose assayed by fingerstick, physical examination, and olfactory test will be conducted. At the end of the study, all of the assessments will be performed again for all recruited subjects, including early withdrawal patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes mellitus ;
* Aged:40 -75 years ;
* Cognitive function assessment suggests normal status or mild cognitive impairment;
* a stable dose of metformin monotherapy (≥1,500 mg daily) for at least 90 days,
* HbA1c 7 - 10%;
* ≥6 years of education;
* Right-handed.

Exclusion Criteria:

* patients unable to complete brain MRI scanning;
* nasal disease that affected olfactory function;
* hepatic dysfunction with liver transaminases \> 2.5 times upper normal limits and renal impairment with an estimated glomerular filtration rate \< 60ml/min/1.73m2 ;
* acute cardio/cerebrovascular disease, psychiatric disorders, pancreatitis, acute infection, malignant tumor,thyroid disease and homorne drug use;
* a history of related drug allergy;
* alcohol or drug misuse;
* pregnant, breast-feeding or intending to become pregnant.
Ketones and Muscle Protein Synthesis

Ketones are natural substances normally produced by the body during prolonged fasting and starvation, or in response to a "ketogenic" diet to be used as fuel by the brain and muscles. Ketones are therefore similar to dietary proteins, carbohydrates and fats since they represent a source of energy for the body. In addition to serving as a source of energy, ketones have also been shown to stimulate increased rates of muscle protein synthesis in humans.

The ingestion of dietary protein is well established to stimulate an increase in the rate of protein synthesis in skeletal muscle. The rate of muscle protein synthesis can be maximized following the intake of 20g of protein. As a result, smaller doses of protein (i.e. 10g) represent a sub-optimal dose of protein because there is still room for improvement concerning muscle protein synthesis.

Recently ketone-containing food products have become available that elevate ketone levels in the body without the need for ketogenic diets or prolonged fasting. Therefore, the purpose of this study is to measure skeletal muscle protein synthesis rates after ingesting the following:

1. Ketone monoester
2. Ketone monoester supplemented with sub-optimal dose of whey protein
3. Sub-optimal dose of whey protein

It is hypothesized that muscle protein synthesis rates will increase following the ingestion of a ketone-containing beverage. Further, muscle protein synthesis rates will be enhanced when the ketone-containing beverage and sub-optimal protein dose are taken together.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged between 18-35 years inclusive
* Healthy, moderately active
* BMI \< 30 kg/m2 and \> 18.5 kg/m2
* Having given informed consent

Exclusion Criteria:

* Presence of any identified metabolic or intestinal disorders
* Use of tobacco products
* Allergies to milk proteins (whey or casein)
* Lactose intolerance
* Phenylketonuria (PKU)
* A history of neuromuscular problems
* Previous participation in amino acid tracer studies
* Adherence to a strict vegetarian or vegan diet
* Current use of ketone supplements or adherence to a ketogenic diet
* Use of medications known to affect protein metabolism
* Diagnosis of Diabetes
* Engagement in sports or physical exercise 5 or more days per week
Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years

Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. The scale self-assessment of the fear that we have developed consists of six faces representing a gradual level of fear: the child can easily describe their level of fear, which allows for appropriate care.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 12 years.
* Enrolled in one of the participating institutions in the study (steps 1-5) or consultant pediatric emergencies at the Children of Limoges (step 6).
* Authorization of at least one person having parental authority for the child to participate in the study.
* Children affiliates or benefiting from a social security

Exclusion Criteria:

* Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions.
* Children in vital emergency
The Effect of Salmeterol on Eosinophil (EOS) Function

This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* history of asthma symptoms for the previous 6 months
* Forced Expiratory Value (FEV1) \>75% of predicted
* positive prick skin test to cat, house dust mite or ragweed

Exclusion Criteria:

* history of life threatening asthma or anaphylaxis
* current smoker
* pregnant or breast-feeding
* evidence of an upper respiratory infection within 4 weeks of screening
Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System

The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). The investigators hypothesized that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.

The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). We hypothesize that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.A total sample of forty participants (N = 40; mean age 26.6 ± 6.7 years) were recruited for participation in the study. Prior to entering the study, all participants received information about the study and signed a consent form to participate. The study subjects were divided into two equally distributed groups (A: NESA = 20; B: Placebo = 20) and were blinded to the study group allocation. Participants in the placebo group underwent the same procedural phases as those in the intervention group. However, for the placebo group, the device was set to deliver a low-intensity current below the sensory threshold, effectively rendering it inactive from the participants' perspective.

Eligibility Criteria:
Inclusion:

- Age between: 18-55 years, both sexes.

Exclusion:

* Cardiovascular disease.
* Specific pharmacology.
* Hypertension.
* Diabetes.
* Systemic diseases.
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations

The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.

This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug is assigned by chance), parallel (a clinical trial comparing the response in two or more groups of participants receiving different treatments), open-label (all people know the identity of the intervention) single-dose, inpatient/outpatient study in healthy participants. The study consists of following periods: Screening (within 28 days before study drug administration), inpatient period (Day 1 to 4) and outpatient period (up to Day 141). Eligible participants will be randomly assigned in a 1:1 ratio to either 1 of 2 treatment groups (that is, Ustekinumab 90 mg/mL or Ustekinumab 5 mg/mL) and will receive treatment on Day 1. The PK comparability of 2 different formulations of ustekinumab, diluted in saline, will be evaluated primarily. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive and a body mass index (BMI) of 18.5 kilogram per square meter (kg/m\^2) to 29.0 kg/m\^2, inclusive
* If a woman, she must be incapable of pregnancy or using a highly effective method of birth control
* A woman must have a negative serum pregnancy test
* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Are nonsmokers or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study

Exclusion Criteria:

* Participant currently has or has a history of any clinically significant medical illness or medical disorders including malignancy
* Participant has previously received ustekinumab
* Participant has a known or suspected intolerance or hypersensitivity to any biologic medication including ustekinumab
* Participant has received an investigational drug within a specified period prior to the planned first dose of study drug or is currently enrolled in an investigational study
OSA Prevalence in Atrial Fibrillation Patients: Jordanian Study

Current Knowledge:

Countless studies have been conducted to study the relationship between OSA and AF, and a significant association has been established between both diseases, owing to the numerous shared risk factors and a wide variety of pathophysiological changes resulting from both diseases being relevant to each other. Our study inspects this relationship from a cardiovascular standpoint, examining the prevalence of OSA in existing AF patients, which could be interpreted as AF being a risk factor for OSA development.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 or above

Exclusion Criteria:

* Unable to give research consent
* Patients who were unwilling to complete the questionnaires
* Patients who suffer from mental illness
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Homozygous Familial Hypercholesterolemia

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study
A Study to Learn More About Tukysa Once it is Out in the Korean Market

The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea.

This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.

The purpose of this study is to understand the safety of Tukysa (Tucatinib hemiethanolate) once it is out in the Korean market. Tukysa will be given to participants aged 18 or over in Republic of Korea.

Surveillance Design Patients with the approved indication who are treated with TUKYSA within the local label will be enrolled.

Adverse Events (AEs) will be collected in the usual practice during administration and for 28 days following cessation of TUKYSA, and ORR will be evaluated through radiographic imaging in the usual practice. The total follow-up period will not exceed 1 year.

Safety

Through the evaluation the safety profile of TUKYSA including important identified risks, Important potential risks, missing information, which are defined about TUKYSA in table2, will be examined. Drug safety is evaluated through the following items:

Efficacy Drug efficacy will be evaluated through the BOR. The ORR which is defined as the proportion of the subjects in the analysis population who have best response as CR or PR will be presented.

Surveillance for long-term use The follow-up period for each patient will vary according to tumor response, treatment of TUKYSA and others. Any patients who are treated with TUKYSA for more than or equal to 180 days including dose interruption will be evaluated for surveillance for long-term use.

Eligibility Criteria:
Inclusion criterias.

1. Patient who is treated with TUKYSA according to the current TUKYSA label for the approved indication.
2. Patient who is treated with TUKYSA for the first time.
3. Patient who is aged 18 or over.
4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criterias.

1. Patients to whom TUKYSA is contraindicated as per the local labeling Note: The summary for any patients who are violated in the inclusion/exclusion criteria (i.e. protocol violation case) will be separately done if collected and described in the separate section of the report.
Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the treatment of psychomotor confusion in patients who are recovering from heart surgery.

Study design:

Multi-centre, prospective, randomised, placebo-controlled double-blind study of dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery. Data will be analyzed in two steps: The primary comparison is between placebo and dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison between dexmedetomidine and haloperidol will follow.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* Clinical need for treatment of psychomotor confusion unresponsive to standard analgesic medication (RASS +2 to +3)
* Heart surgery and extracorporeal circulation (ECC) within 7 days
* Written informed consent obtained before surgery
* Mentally competent at the time of written informed consent

Exclusion Criteria:

* Ongoing neuroleptic, propofol and α2 agonist medication
* Intubated patient
* Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure \< 55 mmHg despite volume, vasopressors and IABP)
* Severe bradycardia without pacemaker backup (heart rate \< 50 beats/min)
* AV-conduction block II-III (without pacemaker backup)
* Severe hepatic impairment (Serum bilirubin \> 101 µmol/l)
* Lithium therapy
Effects of PSAPs on Speech Processing

Mild to moderate hearing loss remains undertreated, largely because of the high cost of hearing aids. A promising and much less expensive alternative is the use of personal sound amplification products (PSAPs), which are electronic, portable, over-the-counter devices that amplify sound. Studies have shown that the use of PSAPs provides significant hearing benefits and improves the quality of life for older adults with mild to moderate hearing loss. However, there is insufficient data to determine the impact of PSAPs use on speech processing in the brain.

The purpose of this study is to use electroencephalography (EEG) measurements to assess the neurobiological and behavioral effects of PSAPs on speech perception in noise in individuals with mild to moderate hearing loss.

The investigators expect that the PSAPs use will result in an immediate improvement in the ability to perceive speech-in-noise, supporting that these hearing devices may be a means of restoring communication skills in people with mild to moderate hearing loss. Behavioral benefits will be associated with increased brain activity in auditory regions and connectivity between auditory and speech regions in the brain.

This study will consist of two sessions of 3 hours each. On one session, participants will perform the speech-in-noise task without hearing devices and on the other session, participants will perform the speech-in-noise task while wearing personal sound amplification products. The order of the sessions will be counterbalanced across participants. The speech-in-noise task consists in a word discrimination task in babble noise at three signal-to-noise ratios. On each trial, the task is to determine whether two words are identical or different.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed

Exclusion Criteria:

* Mother tongue not English
* Language impairment
* Dementia
* Cerebrovascular diseases
* Untreated vision impairment;
* Tinnitus and otologic disorders
* Cochlear implant
* History of prior hearing aid use
* Diagnosed addiction (alcohol or drugs)
* Significant medical or neurocognitive conditions or interventions likely to significantly impact cognitive function (e.g., epilepsy, stroke, traumatic brain injury with loss of consciousness \> 5 minutes, brain tumor, multiple sclerosis, hepatitis C, developmental delay, electroconvulsive therapy)
* a diagnosis (based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) of major depressive disorder with active symptoms within 90 days of study entry, past or present psychosis, or other psychiatric disorders such as obsessive-compulsive disorder, generalized anxiety disorder, and bipolar disorder