cyrilzakka/clinical-trials huggingface dataset:
Metabolomics Dynamics Study for Severe Patient

Acute severe disease is a major public health challenge that often affects young adults.In past decade, there are lot of new techniques have been developed that aim to improve the outcome of acute severe disease, But few of these works success. According to recently studies, the mortality of the multiple organ dysfunction syndrome（MODS) that is the major cause of death in patients who suffering from acute severe disease, is not improved. On the contrary, if MODS be predicted in early stage of acute severe disease, the death can be prevented. Because acute severe disease poses complex injury that involves multiple pathological processes, understanding the cellular and metabolic network malfunction during acute severe disease is crucial for clinical monitoring and intervention.

Human metabolism is a complex network with hundreds of cross-linked paths. During critical illness, the metabolic network is dynamically disturbed at multiple points. Classical research typically isolates a small part of this network to investigate the impact of pathological physiology molecular mechanisms on clinical outcome. In particular, researchers have examined metabolic disturbances such as cytokine network dysfunction, skeletal muscle breakdown, insulin resistance, dyslipidemia, testosterone and growth hormone/Insulin like growth factor （IGF）dysfunctions, low thyroxine syndrome, and deficiency of vitamin D and calcium with secondary hyperparathyroidism. These complex metabolic disturbances appear and interact at different stages during the pathological process after acute severe illness. Therefore, an integrated approach that combines the biochemical/molecular changes with network disturbances is the key to understanding acute severe illness at the systems biology level and establishing an accurate quantitative model for clinical monitoring.

An interdisciplinary method that includes high-throughput quantitative techniques and effective mathematical and visualization tools is necessary. Furthermore, interdisciplinary methods present the opportunity to develop innovative clinical diagnosis and monitoring methods for severe injuries. The aim of this study is to provide a novel high-throughput method that integrated proton-nuclear magnetic resonance (NMR) metabolomic fingerprinting and High Performance Liquid Chromatography with advance mathematics tools to modeling metabolic dynamics after acute severe disease.


Eligibility Criteria:
Inclusion Criteria:

* Age:18-70 years
* Acute Physiology And Chronic Health Evaluation(APACHE)II\>10

Exclusion Criteria:

* With comorbidity (Diabetes,Hyperthyroidism or primary organ dysfunction )
* Pregnancy
Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma

Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL).

The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologically verified diagnosis of cHL, refractory or relapsed after the first line of therapy
* Age 18-70 y
* Ejection fraction not less than 50%
* No severe concurrent illness
* 0-2 ECOG status
* Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug.

Exclusion Criteria:

* Severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms;
* Respiratory failure \> grade 1 at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Active or prior documented autoimmune disease requiring systemic treatment
* Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
* Hypersensitivity or allergy to study drugs
* Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
* Simultaneous use of drugs or medical devices studied in other clinical trials
* Use of PD-1 inhibitors or bendamustine in the 1st line of therapy
Potential Association of a Common L-FABP Polymorphism With Lipid-induced Hepatic Insulin Resistance

The investigators hypothesise that a common A277G polymorphism of the liver fatty acid binding protein (L-FABP) gene, which leads to an amino acid exchange, may be associated with alterations of lipid-induced hepatic insulin resistance. In the present study the investigators will investigate potential differences in lipid-induced hepatic insulin resistance, and in the relation between glycogenolysis and gluconeogenesis, in healthy subjects with the A277G polymorphism vs. subjects carrying the wildtype.

Liver fatty acid binding protein (L-FABP) is an abundant cytosolic lipid-binding protein that regulates lipid transport and metabolism. Only one common non-synonymous polymorphism (A227G) leading to an amino-acid exchange in the exonic region of the L-FABP gene has been previously identified. Experimental elevations of free fatty acids (FFAs) have been shown to impair insulin mediated suppression of endogenous glucose production (EGP). Deletion of the L-FABP gene shows no obvious phenotype in mice receiving a low fat chow diet, but leads to decreased hepatic triglyceride accumulation in the prolonged fasted state, which exposes mice to an increased fatty acid flux to the liver. The function of the L-FABP gene may be altered by polymorphisms in coding regions of the gene, probably leading to modifications in hepatic triglyceride accumulation and hepatic insulin resistance.We hypothesize that carriers of the A277G SNP, when compared to matched wild-type subjects, may show altered responses of hepatic glucose production upon exposure to increased peripheral fatty acid concentrations, as achieved by lipid / heparin infusions. Because it is known that free fatty acids potently increase insulin secretion, we use somatostatin clamps in our experiments, followed by replacement of postabsorptive insulin and glucagon concentrations.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects with normal glucose tolerance (NGT)

Exclusion Criteria:

* any severe cardiac, liver, or kidney diseases
* pregnant or lactating women, menstrual irregularities
* cortisone, antidiabetic drugs
Postmarketing Surveillance to Investigate the Safety and Efficacy Information of Alesion® Tablet

Study to investigate the safety and efficacy information of Alesion® Tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching


Eligibility Criteria:
Inclusion Criteria:

All the patients who:

* haven't treatment experience of epinastine product;
* have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, prurigo, urticaria, psoriasis with itching, bronchial asthma

Exclusion Criteria:

* Alesion® Tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Tablet in package insert. However, it is unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey is drug utilization study to observe actual use in any patients. Therefore exclusion criteria is not set in the protocol
Pre-Operative Assessment of Chest Wall Invasion in NSCLC Using Pre-Operative, Surgeon Performed Ultrasound

Non-Small Cell Lung Cancer (75% of lung cancer) is associated with involvement of the parietal pleura and or chest wall (soft tissue and/or bone) in 5-8% of patients. Invasion of the chest wall increases the T staging in the Tumor, Node, Mestasis (TNM) classification system of lung cancer to a T3 and is associated with decreased survival and more extensive operative procedures. The reported 5-year survival for patients with T2 tumors is 58% compared to 38% in patients with T3 lesions. The American college of Chest Physician has still not identified the best tool to assess chest wall invasion by lung cancer, CT-Scan being used by physicians for this assessment. In some studies, CT scan has been shown to have a sensitivity ranging from 42 % to 68 % in assessing chest wall invasion, and a specificity ranging from 66 % to 100 %.

Trans-thoracic Ultrasound (US) has the capacity of allowing for dynamic real-time imaging of the pulmonary lesion and the chest wall. Therefore, US has the potential to allow for the appreciation of subtle findings related to the movement of the lesion and lung over the chest wall. Hence, US might be an accurate tool to assess chest wall invasion by lung cancer; thus improving pre-operative diagnosis, staging and operative planning of patient with chest wall invasion.

However US is not currently utilized in the pre-operative assessment of patients with lung cancer invading the pleura and chest wall, and has not been extensively studied.

In some rare studies evaluating the accuracy of US, results have shown a sensitivity ranging from 89% to 100% and a specificity ranging from 95% to 98% for US detecting chest wall invasion by lung cancer. However those studies got criticized. Bandi et al study, got criticized by the fact that the operators in the study were experienced interventional pulmonologists who perform hundreds of thoracic and endoscopic ultrasound per year. Nobuo et al study took place in 1993, since when the device of US has evolved, the investigators can not apply with certainty the findings of this study.

Consequently, there is a need to conduct a study to evaluate the accuracy of US to assess chest wall invasion by lung cancer.

In this prospective study the investigators will assess the accuracy of US, and then compare it to the accuracy of the CT-Scan


Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral pulmonary nodules abutting the visceral pleura on pre-operative CT scan of the chest and who are booked for surgery.

Exclusion Criteria:

* Inability to consent for the study.
* Patients less than 18 years old.
An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy

This is an observational, study of dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study.


Eligibility Criteria:
Inclusion Criteria:

* Attending an ophthalmology consultation for LASIK

Exclusion Criteria:

* None
MK0686 in Postsurgery Dental Pain (0686-002)

To compare the pain relieving effect of MK0686 to placebo or ibuprofen after dental surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-45 years who are scheduled to have 2 or more third molars (wisdom teeth) removed
* Patients must agree to remain in the clinic for 24 hours after surgery

Exclusion Criteria:

* Patient has history of heart disease, asthma, pulmonary disease
* Patient must discontinue use of certain pain medicines 24-72 hours prior to the surgery
New Method Using Deuterium Labelled Creatine to Measure Total Body Skeletal Muscle Mass

Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of muscle mass. The method uses a dose of deuterium-labelled creatine to determine total skeletal muscle mass via estimation of total body creatine pool size.The aim of this study is to compare estimates of total body skeletal muscle mass by D3-creatine dilution method and whole body Magnetic Resonance Imaging (MRI) in an athletic population.


Eligibility Criteria:
Inclusion Criteria:

* Trained and competing elite canoe athletes will be recruited, who represent Great Britain Canoeing

Exclusion Criteria:

* Pregnant and lactating women
* Intolerance or hypersensitivity to Creatine supplementation
* Athletes with disabilities which affect their total body muscle mass
* If creatine was taken in a supplemented form, rather than dietary intake, more regularly than once a week within 6-weeks of assessment commencing
* Contraindication to an MRI scan
Inspiratory Muscle Training in COPD

This proposal aims at evaluating an inspiratory muscle training (IMT) method not previously tested in COPD called the Test of Incremental Respiratory Endurance (TIRE). As a training method, TIRE promises to provide further benefits over standard IMT because it allows the user to adjust training loads as progress is made, adjusts the training based on day-to-day variations commonly noted in COPD, and provides a graphic representation of the inspiratory effort throughout all inspiration with real-time biofeedback in order to "coach" the user in performing the exercises. The TIRE device can also be used as an assessment tool, not only to measure the commonly used measure of inspiratory muscle strength Maximal Inspiratory Pressure (MIP), but also measuring the MIP variation generated throughout a maximal sustained inspiration. In this way, TIRE integrates MIP over the inspiratory duration (ID), providing a novel derivative measure called the sustained maximal inspiratory pressure or SMIP, that is likely a better surrogate of inspiratory muscle performance in COPD based upon preliminary data. The main goal of this trial is to fully evaluate the utility of TIRE as an IMT method in veterans with COPD. The investigators hypothesize that as a stand-alone therapy, TIRE training is superior to standard IMT in improving inspiratory muscle strength and endurance and in improving COPD-related clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \> 40 years with a confirmed diagnosis of COPD by a pulmonologist (presence of risk factors and airflow obstruction) and evidence of inspiratory muscle weakness as defined by the latest American Thoracic Society / European Respiratory Society statement on respiratory muscle training.

Exclusion Criteria:

* Refusal to participate in the study, subjects actively undergoing pulmonary rehabilitation, inability to perform the required maneuvers (i.e. patients with cerebrovascular accident or tracheostomy), subjects not in their stable state (i.e. having an acute exacerbation or within 4 weeks of having one) or presence of important comorbidities that may confound the interpretation of TIRE measures (i.e. decompensated heart failure, diaphragmatic paralysis, prior lung surgery, active cancer treatment, etc.). There will be no involvement of vulnerable populations.
Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients

In this study, brain imaging predictive factors related to motor recovery will be investigated. Lastly, the prediction model will be established.


Eligibility Criteria:
Inclusion Criteria:

* Adults more than 19 years
* First-ever unilateral stroke
* Ischemic subacute stroke patients

Exclusion Criteria:

* Major active neurological disease or psychiatric disease
* Metallic implants in their brain
* Hemorrhagic stroke
* Bilateral lesions
* Recurrent stroke
Pre-operative Stress Reduction With Music

The purpose of this study is to assess the effect of music, played prior to a surgical procedure, on stress levels during induction of anesthesia. Hypothesis: playing "calming" music, pre-selected by the investigator and the patient, beginning just prior to induction and terminating after induction will positively reduce the patient's heart rate, blood pressure, and respiratory rate during this period. For this study, noise-cancelling headphones with the ability to play music via an iPod will be utilized.

Reduced stress and relaxation positively contribute to patient healing after surgery (1). Reduction of stress associated with surgery is even more important in children, for whom a traumatic experience can have even more damaging and long-lasting effects (2). One stress-reduction technique of current interest is music. In global studies outside of the surgical realm, music has been shown to reduce heart rate, blood pressure, respiratory rate, and stress hormone levels as well as alleviate anxiety (3).

Evidence has also been found that listening to music pre-operatively in both adult and pediatric cases can reduce patients' stress and anxiety levels before surgery (3,7) Of the studies that have addressed the benefits of pre-operative music, however, none have assessed the impact of pre-operative music on stress levels during induction. In addition, almost all prior studies of the benefits of perioperative music have assessed the effect of only one style of music on each patient group. This set-up is beneficial in eliminating variables within the study design, but it fails to consider the individuality of each patient and what he/she might find to be relaxing. This study aims to assess the effect of music (selected by the pediatric patient from one of several pre-compiled playlists) played pre-operatively and during induction on patient stress levels.

Eligibility Criteria:
Inclusion Criteria:

* Aged 10 - 16 years
* Present to the OR for correction of an orthopedic complaint not involving the head or neck
* Consent to participate in the study obtained from both the guardian and child
* Patients and guardians are English-speaking

Exclusion Criteria:

* Hearing impairments or ear abnormalities
* Pre-existing issues with substance abuse, anxiety, or depression
* Pre-existing psychiatric disorders
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.

Abuse Liability Study

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before Visit 1 (Screening Visit).
* Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).

Exclusion Criteria:

* Diagnosis of substance and/or alcohol dependence
* Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder.
Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs

This is a substudy of ACTG A5142. The purpose of this substudy is to evaluate blood vessel function in HIV-infected patients taking anti-HIV drugs.

Endothelial dysfunction, assessed by measurement of brachial artery reactivity, is associated with coronary artery disease. Previous studies showed that patients taking HIV protease inhibitors (PIs) had a buildup of fatty deposits in their arteries and impaired flow-mediated vasodilation of the brachial artery, whereas endothelial function was normal in HIV-infected individuals not taking PIs. The effect of three different antiretroviral regimens on endothelial function in antiretroviral naïve HIV-infected patients will be examined in this substudy.

Patients in this substudy will have Brachial Artery Reactivity Tests (BARTs), which are painless ultrasound tests of an artery in the lower arm. Brachial artery reactivity will be measured at entry and at 4 and 24 weeks after patients are randomized to one of three open-label drug regimens in ACTG A5142. Brachial artery reactivity in response to two vasoactive stimuli (flow-mediated and nitroglycerin) will be assessed by measuring brachial artery diameter and flow velocity. Blood will be drawn at Weeks 4 and 24 for insulin and lipid tests. Patients will fast and refrain from tobacco and caffeine use for at least 8 hours prior to each study visit. For the duration of the substudy, patients will be asked not to change the amount of fruits, juices, antioxidants, and tea that they consume.

Eligibility Criteria:
Inclusion Criteria:

* Participation in ACTG A5142 .
* Able and willing to give written informed consent and to report current smoking status.
* Men who have been on stable testosterone replacement for at least 3 months prior to entry and plan to continue to receive a stable dose during the substudy may enroll. Men who have discontinued testosterone therapy must be off for at least 3 months to be eligible.
* Women receiving oral contraceptives, hormone replacement, or progestational derivatives must have been on stable regimens for at least 3 months prior to enrollment and must plan to remain on the same dose for the duration of the study. Women who have discontinued such therapy must be off for at least 3 months to be eligible.

Exclusion Criteria:

* Coronary heart disease, peripheral vascular disease, or cerebrovascular disease.
* Diabetes mellitus, with the exception of a previous history of gestational or steroid-induced diabetes mellitus within 12 weeks prior to substudy entry.
* Insulin-sensitizing agents such as metformin, pioglitazone, and rosiglitazone.
* Lipid-lowering drugs within 6 weeks prior to substudy entry.
* Systemic glucocorticoids, long-acting inhaled steroids, and certain anabolic steroids within 30 days prior to substudy entry.
* Uncontrolled hypertension.
* Heavy use of vitamin supplements.