cyrilzakka/clinical-trials huggingface dataset:
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance

To observe the effect of PEEP on CVP among patients with different respiratory compliance

30 patients with mechanical ventilation and inserted central venous line will be entered. After gathering demographic data, patients undergone 5,10 and 15cmH2O PEEPs and the respective CVPs of the mentioned points will be recorded. According to the change of CVP, the patients will be divided into high response group and low response group, then comparing the lung compliance and thorax elastic resistance differences between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mechanical ventilation and inserted central venous line

Exclusion Criteria:

1. The age is less than 18 years old or more than 80 years old；
2. Pregnant and lying-in woman；
3. Patients undergoing fluid resuscitation and the speed is more than 200ml/h；
4. Patients with norepinephrine dose are greater than 15 micro per minute；
5. Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation；
6. Patients with COPD(endogenous PEEP is more than 2cmH2O)、tension pneumonthorax、acute episode asthma
Study Evaluating INS018_055 Administered Orally to Subjects with Idiopathic Pulmonary Fibrosis (IPF)

The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).

The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥40 years based on the date of the written informed consent form
2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
4. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for \> 8 weeks prior to Visit 1
5. Meeting all of the following criteria during the screening period:

   1. FVC ≥40% predicted of normal
   2. DLCO corrected for Hgb ≥25% and ≤80% predicted of normal.
   3. forced expiratory volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value

Exclusion Criteria:

1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
3. Female patients who are pregnant or nursing
4. Abnormal ECG findings

Other protocol inclusion and exclusion criteria may apply.
Value of Triglyceride Glucose Index in Prediction of Cardiac Outcomes in Patients With Acute Coronary Syndrome

Triglyceride glucose index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (MACEs), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure.

We hypothesis that there is a relation between prediction of MACE in acute coronary syndrome patients and between triglyceride glucose index.

Cardiovascular diseases, particularly coronary artery disease (CAD), is considered as a main cause of death and disability in the developed countries as its responsible for about 1 in every 5 deaths In the last few years.

Acute coronary syndrome (ACS), which is the most severe ischemic heart disease including Non-ST-elevation myocardial infarction (NSTEMI), ST-elevation MI (STEMI), and unstable angina has been one of the leading causes of death worldwide which leads to a large social and economic burden.

It has been well recognized that the development of (CAD) is driven by multiple factors including glycemic abnormality and lipid disorders.

Insulin resistance (IR) is a key metabolic abnormality leading to the development of T2DM, and recent studies have also found that it could independently predict the development of cardiovascular disease (CVD). Hyperinsulinemic-Euglycemic Clamp (HIEC), as the gold standard for the diagnosis of insulin resistance, is very difficult to be carried out in clinical work due to its difficulty of operation and equipment requirements.

Triglyceride and glucose index (TyG index) was one of the alternative methods for evaluating insulin resistance and is a novel marker Unlike the homeostasis model assessment and quantitative insulin sensitivity check index, insulin is not included in the TyG index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (MACEs), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure.

The TyG index was calculated as the ln (fasting triglyceride level \[mg/dL\] × fasting glucose level \[mg/dL\]/2) Normal cut-off values reported for the TyG in the literature are roughly around 4 and 8.

Aim of the work

To study the value of triglyceride glucose index as a short term predictor of MACE in diabetic and non diabetic patients presented by Acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome patients

Exclusion Criteria:

* With acute infectious disease, rheumatic disease, hematological disease, or neoplastic disease.
* With severe valvulopathy or cardiomyopathy
* Lacking clinical or follow-up data.
* suspected familial hypertriglyceridemia
A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)

The purpose of this study is to describe the following in relation to the safety of Equfina Tablet 50 mg in the post marketing setting: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with idiopathic Parkinson's disease experiencing end of dose motor fluctuations who are receiving Equfina Tablet 50 mg as adjunctive treatment to levodopa-containing products
2. Participants who have given their consent to study participation about the use of personal data and medical data

Exclusion Criteria:

1. Participants taking over monoamine oxidase (MAO) inhibitors (example, selegiline hydrochloric acid \[HCl\], rasagiline mesylate)
2. Participants taking opioid drugs (example, pethidine HCl containing drugs, tramadol HCl containing products or tapentadol HCl)
3. Participants taking serotonergic drugs (example, tricyclic antidepressants, tetracyclic antidepressants, selective serotonin reuptake inhibitor, serotonin-noradrenaline reuptake inhibitors, selective noradrenaline reuptake inhibitor, noradrenergic and serotonergic antidepressant) or psychostimulant drugs (example, methylphenidate HCl, lisdexamfetamine dimesylate)
4. Participants taking dextromethorphan
5. Participants with severe hepatic impairment (Child-Pugh C)
6. Participants with a history of hypersensitivity to any of the ingredients of Equfina Tablet 50 mg
7. Pregnant women or women who may be pregnant
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p53 gene into the tumor may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Combining chemotherapy with gene therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene therapy in treating patients who have stage III or stage IV breast cancer.

OBJECTIVES:

* Determine the therapeutic efficacy of docetaxel, doxorubicin, and Ad5CMV-p53 gene in patients with locally advanced breast cancer.

OUTLINE: Patients receive p53 gene by intralesional injection on days 1 and 2. Patients also receive doxorubicin IV over 15 minutes followed 1 hour later by docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses. After completion of chemotherapy, patients with a reasonable response undergo surgical resection.

PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Stage IIIA, IIIB (excluding inflammatory breast carcinoma), or IIIC OR
  * Localized stage IV
* Measurable disease
* No metastases
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 18 and over

Sex

* Male or female

Menopausal status

* Not specified

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Adequate bone marrow function

Hepatic

* Adequate liver function
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative

Renal

* Adequate kidney function

Cardiovascular

* Normal cardiac function by MUGA and/or echocardiogram

Other

* No psychological, familial, sociological, or geographical conditions that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective barrier method of contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior gene therapy using adenoviral vectors or p53 gene product

Chemotherapy

* No prior chemotherapy for breast cancer

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Bariatric Surgery in Children.

Rationale:

In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.

The standard treatment for morbid obesity in children is by combined life style interventions. However, the medium and long term effects of dietetic interventions, behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good results with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in this age group is only allowed in clinical trials, until the benefits and risks have been established. (National Health Authorities)

Objective:

To determine if surgery gives a superior weight and body mass index (BMI) reduction than combined life style interventions in adolescents with morbid obesity and to assess its effect on obesity associated co-morbidity.

Study design:

Prospective randomised interventional study.

Study population:

Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI \>40 kg/m2 or \>35 kg/m2 with co-morbidity.

Intervention:

Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style interventions

Main study parameters/endpoints:

Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary endpoints: Body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain development, quality of life, and behaviour changes. The potential complications of surgery are monitored.


Eligibility Criteria:
Inclusion Criteria:

* Aged 14 to 16
* Age and sex adjusted BMI \>40 kg/m2 or \>35 kg/m2 with associated co-morbidity.

  \* Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
* \> 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
* Demonstrate decisional capacity

Exclusion Criteria:

* Psychologically not suitable
* Pre-menarche or bone age \<15 years in boys
* Obesity associated to other disorders such as hypothyroidism
* Syndromal disorders such as Prader-Willi syndrome
* Severe cardiorespiratory impairment (ASA class 3 or higher)
* Insufficiently fluid in the Dutch language
* Unwillingness to adhere to follow-up programmes
Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis

Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.

This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11

Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.

This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11 patients with active takayasu's arteritis

Eligibility Criteria:
Inclusion Criteria:

* active takayasu's arteritis

Exclusion Criteria:

* active Tuberculosis
* Liver function abnormality
* heart failure ( New York Heart Association III - IV)
* patients were not consented
Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings

Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy will be performed.

Purpose: To determinate the incidence, pathological significance and risk factors associated with the presence of solitary dilated duct visualized at mammography exam.

Methods: Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be included in the study. These patients will be recalled in order to be submitted to an ultrasonography directed to the mammographic finding. Patients who present lesions on ultrasonography will undergo method-guided percutaneous biopsy.

Patients with ductal ectasia, without evident lesions, will be followed for 2 years to evaluate stability by means of mammography or ultrasonography every 6-month intervals.

Eligibility Criteria:
Inclusion Criteria:

* Identification of a solitary dilated breast duct at mammography

Exclusion Criteria:

* Previous breast surgery at same side of detection of dilated duct
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these subjects. Data of parameters such as patient and graft survival, comorbidity, treatment of graft rejection episodes and quality of life as well as anti-drug antibody levels will be collected.

This prospective, observational follow up study of subjects who have received imlifidase prior to kidney transplantation will provide important data to future prescribers and patients of the potential long-term benefits of imlifidase mediated transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent obtained before any study-related procedures
* Previous dosing with imlifidase followed by kidney transplantation and participation in one of the following clinical studies: 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 or 15-HMedIdeS-06

Exclusion Criteria:

* Individuals deemed unable to comply with the protocol
* Inability by the judgment of the investigator to participate in the study for other reasons
Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores

Breast milk is the best food during the first 6mo of life because it offers multiple benefits for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low vitamin A concentration has been observed in northwest Mexico, which can affect the human milk composition and increase the risk of VAD in breastfed babies. An individualized dietary intervention in the lactating woman will reduce body weight and improve vitamin A status. The objective is to assess the effect of an individualized dietary intervention during 3 months postpartum on body composition and vitamin A status of lactating women.

This protocol was approved by the Bioethics Committee of the Department of Medicine and Health Sciences of Universidad de Sonora. A randomized controlled trial will be carried out and participant women will be assigned by simple randomization 1:1 to either the intervention or control group, upon signing an informed consent. At baseline (2wk postpartum), anthropometric (weight, height, mid upper-arm circumference and triceps skinfold thickness) and body composition (DXA) measurements as well as the assessment of vitamin A status (serum and breastmilk retinol and the modified relative dose response) will be performed. The control group will receive only recommendations for a healthy diet in accordance with international standards and will be followed up every month to promote adherence and to assess their nutritional status. On the other hand, the intervention group will receive an individualized macronutrient meal equivalent menu, with nutritional consultations every two weeks. The dietary plan will include 1-1.5 g/kg body weight protein, 30% total fat (preferably mono and polyunsaturated fatty acids), and vitamin A sources (1300 RAE). After 3 months of intervention are completed, baseline measurements will be repeated. Statistical analysis will include descriptive stats and comparisons between groups (t-tests), significance will be defined as P \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25
* Predominant breastfeeding
* Signed Informed Consent

Exclusion Criteria:

* Multiparity
* Alcohol, drugs, tobacco intake
* Use of dietary supplements
* Active infection (C reactive protein \> 6mg/L)
* External nutritional counseling
* Pregnancy during the study period
* Liver disease
Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults

The purpose of this study is to evaluate the concurrent validity between the Brain Performance Test (BPT) subtests and corresponding conventional in-person neuropsychological assessments (NP).

This will be a multi-site, randomized, counterbalanced, two-period, two-sequence, validation study of the online, unsupervised Brain Performance Test (BPT). Over the course of 14 days, participants will complete two in-clinic visits during which they will complete both the BPT and in-person neuropsychological assessments (NP).

Eligibility Criteria:
Inclusion Criteria:

* Native English speaker
* Capable and willing to provide informed consent
* Able to use a computer and mouse without assistance
* Limited (\< 3 days) or no experience with Lumosity.com
* Limited (\< 3 days) or no experience with other cognitive training programs (e.g., FitBrains, CogMed)
* Willing to refrain from online cognitive training during the course of the study
* No recent (\<1 years) experience with either computer-based or in-person neuropsychological tests (e.g., WAIS-IV, WISC, Halstead-Reitan Battery, MATRICS, CogState, CNS Vital Signs)
* Good general health assessed via self-reported online physical questionnaire and medical history questionnaire

Exclusion Criteria:

* Illiterate or unable to understand written English sufficiently to comprehend study instructions and consent form
* Uncorrected visual impairment (beyond that required to qualify for a California Driver's License) that may impact the ability to complete assessments (self-report or determined by the clinician)
* Uncorrected auditory impairment that may impact the ability to complete assessments (self-report or determined by the clinician)
* Self-reported clinical diagnosis for primary psychiatric or neurological disorder (e.g., schizophrenia, multiple sclerosis, attention deficit hyperactivity disorder, Parkinson's disease, epilepsy)
* Self-reported history of concussion or traumatic brain injury, that is considered clinically significant in the opinion of the investigator (e.g. loss of consciousness ≤ 30 minutes)
* Self-reported diagnosis of mental retardation or pervasive developmental disorder
* Self-reported diagnosis of Mild Cognitive Impairment, Alzheimer's disease, or other dementia
* Self-reported history of sustained substance or alcohol abuse or dependence, that is considered clinically significant in the opinion of the investigator (e.g. as defined by DSM-5)
* Self-report that subject is currently taking an antipsychotic, antidepressant, anti-anxiety, or a cognitively-enhancing medication (e.g. Ritalin), or in the last 72 hours, narcotics for pain or other medications that may impact cognitive performance (e.g. sleeping medications/aides or cold/allergy medications)
* Any other significant medical condition that could impact cognitive performance or result in cognitive impairment in the opinion of the investigator
* Score \<28 on the MMSE
* Positive urine test for recent substance use on either testing day
* Breath Alcohol Content of 0.01% or greater on either testing day