cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

Patients who are able to understand and willing to sign the informed consent form (ICF).

* All patients should aged 14 to75 years,no gender limitation.
* Patients who are newly diagnosed with AML(no M3).
* Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
* Renal function: creatinine ≤the upper limit of normal;
* Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
* The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
* Patients without severe allergic constitution.

Exclusion Criteria:

* Patients with allergy or contraindication to the study drug;
* Female patients who are pregnant or breast-feeding.
* Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
* Patients with mental illness or other states unable to comply with the protocol;
* Less than 6 weeks after surgical operation of important organs.
* Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\> 2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal;
* The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
Fit 24 Technology Intervention YOUTH

The purpose of this study is to examine the effects of a goal-setting intervention that utilizes a Fitbit device and text messaging to improve physical activity and sleep in Hispanic adolescents with obesity.

Hispanic adolescents are disproportionately burdened by obesity and type 2 diabetes compared to non-Hispanic white youth. Disparities in T2D emerge early in life and are driven in part by unhealthy lifestyle behaviors including low levels of physical activity, excessive time spent in sedentary behaviors and short sleep durations. Given that Hispanic youth are the fastest growing pediatric subgroup in the U.S., developing strategies to promote healthy lifestyle behaviors and addressing T2D disparities is a public health imperative. Wearable activity monitoring devices like Fitbits are designed to continuously monitor both wake time and sleep behaviors. Therefore the purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a 12-week technology-based intervention that uses a Fitbit and text messages grounded in the Self-Determination Theory to promote healthy lifestyle habits and reduce risk for type 2 diabetes among a Hispanic adolescents with obesity.

Eligibility Criteria:
Inclusion Criteria:

* Self identify as Hispanic or Latino
* obese, defined as body mass index percentile (BMI%) ≥ 95th percentile
* Ages of 14-16 years
* Own his or her own cellphone.

Exclusion Criteria:

* Taking a medication(Steroids) or diagnosed with a condition (i.e. sleep (i.e. sleep apnea) that influences activity, sleep, and/or cognition
* Recent hospitalization or injury that prevents normal physical activity
* pregnant
* currently enrolled in an exercise program or currently using a personal activity monitoring device like Fitbit.
Point-of-care Ultrasound Interest in Acute Gastrointestinal Bleeding Emergency Department Patients

Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department. The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as 10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. Currently, few studies have examined the value of echocardiography in the management of patients presenting for Acute GI Bleeding in the Emergency Department. The main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Primary reason for emergency Department admission is acute gastrointestinal bleeding

Exclusion Criteria:

* Pregnant or breastfeeding women
* Persons not benefiting from a social security scheme
* Persons deprived of liberty
* Patient participates in another study
* The patient is in a period of exclusion determined by a previous study.
* The patient is under legal protection, guardianship or trusteeship.
* Patient refuses to participate
* It proves impossible to give informed information about the subject matter
* The patient is not fluent in French.
Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures

Transnasal Flexible Pharyngolaryngoscopy (NPL) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.In the studies the desired properties for an effective topical agent to be used in patients undergoing NPL. To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain. However, to date, no studies have been performed in which intranasal hypertonic saline was used prior to nasal endoscopy.

NPL is a technique that has been used for more than 100 years and increases brightness, magnification and the ability to take still and video images (3). NPL is a simple, safe, cost-effective, and generally well-tolerated procedure. However, a portion of patients may refuse to allow the procedure to be repeated as they find it uncomfortable, intolerable, or painful.To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain and increase the field of view and to reduce the duration of examination and unpleasant sensations for the patient on NPL procedures.This randomised control trial was undertaken to compare the application of nasal hypertonic sea water (3.5%) with nasal lidocaine 10%, topical nasal decongestant xylometazoline 0.1% (OtrivineTM) and nasal isotonic serum physiologic as placebo group in relation to how they effectively improve the adequacy of the examination and if they reduce pain and discomfort associated with endoscopic nasal examination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who undergone diagnostic nasal endoscopy between 2015- 2017

Exclusion Criteria:

* Had experienced nasal endoscopy before
* Pregnant
* Allergic to either xylometazoline or lidocaine
* Asthma
* Cardiovascular disease
* Rhinitis
* Severe septal deviation
Circulating Tumor DNA As Liquid Biopsy in Patients with Stage IV Solid Tumors, a Feasibility Study At MUSC HCC

1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.
2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when available, with those of primary tumor and metastasis.

The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic acid. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. This reaction will be measured by studying patient blood that will be collected before and during treatment until there is disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of stage IV malignancy, including any advanced solid tumors (including lymphoma)
* Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-3
* Life expectancy ≥ 3 months
* Patients must be able to provide consent
* Patients can be enrolled in other interventional clinical trials

Exclusion Criteria:

- Age \< 18-year-old
Anti-Müllerian Hormone (AMH) Measured With Fully Automated Assay Versus AFC in the Prediction of Ovarian Response

The primary objective of this prospective, observational, multivariate study will be to compare the reliability of automated AMH (measured with Access AMH assay, Beckman-Coulter Diagnostics, USA) with that of antral follicle count (AFC) evaluated ultrasonographically always by the same operator and with the same ultrasound scanner, in terms of the number of oocytes recovered from oocyte sampling in couples subjected to in vitro fertilization.

Individual variability in ovarian response to a starting dose of gonadotropins is a well-known aspect during controlled ovarian stimulation (COS) and many efforts have been made for obtaining the personalization of the treatment, identifying different biomarkers that may predict the ovarian response such as age, basal Follicle Stimulating Hormone (FSH), AMH and antral follicle count (AFC). The number of oocytes retrieved is the main expression of ovarian response and it remains a relevant prognostic marker in women undergoing In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) cycles. Consistent evidence shows that an optimal - rather than a maximal - oocyte yield is the preferred achievement after COS when fresh embryo transfer is scheduled. In fact, live birth rates steadily increase when an optimal number of oocytes is collected, whereas low response and hyper-response are associated with lower implantation rates, increased obstetrical risks and, at least when considering hyper response, increased risk of ovarian hyperstimulation syndrome (OHSS) in the fresh cycle. Among the different biomarkers, AMH and AFC seem to have the best performance in predicting ovarian response to exogenous FSH.

Nevertheless, until now, there is often discordance between the AMH level and AFC in clinical practice. In cases of discordance, which indicator should be chosen to individualize the starting dose of gonadotropins? Until now, no direct comparison of the new automated immunoassay of AMH with AFC has been carried out considering the number of retrieved oocytes as primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

BMI between 18 and 30 kg/m2, basal serum day 3 FSH ≤ 15 IU/l, normal regular menstrual cycles, ranging from 25 to 33 days in length, normal thyroid-stimulating hormone (TSH) and prolactin levels, normal uterine cavity as assessed by hysteroscopy or sonohysterography or three-dimensional ultrasound and presence of both ovaries.

Exclusion Criteria:

irregular menstrual cycles, severe endometriosis, defined as stage III-IV of the American Society for Reproductive Medicine (ASRM) revised classification, previous ovarian surgery, presence of ovarian cysts, polycystic ovary syndrome, use of hormonal contraception in the previous 3 months and use of gonadotrophins in the previous 3 months, any known metabolic or endocrinological disease
Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years
* refractory or advanced cardiogenic shock prior to institution of VA-ECMO

Exclusion Criteria:

* History of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (GFR) less than 60 mL per min
* Cognitive impairment
* Pregnant women
* patient or surrogate is not fluent in English
* Long-term immunosuppression
The Influence of Daily Honey Consumption on IR in Obese Women with IR

The main objective of the study is to evaluate the effects of daily honey consumption on insulin resistance as a preventive measure against diabetes. in women with insulin resistance.

The prevalence rates of insulin resistance (IR) and its health consequences are increasing worldwide. The reputation of honey as a healthy alternative for sugar is largely accepted. Honey contains several bioactive constituents; however, its effect on IR measures and glycemic control is yet to be assessed. We aim to evaluate the effect of daily consumption of honey on IR and inflammatory status measures in obese women with insulin resistance in a free-living controlled intervention study. Sixty obese adult females with insulin resistance will be recruited from the community of the University of Jordan and from patients at the Endocrine unit at the University of Jordan Hospital. Participants will be randomly assigned into one of two treatment groups, honey group or jell-O group. Participants will consume a daily dose of 0.5 mg per kg of body weight of the prescribed treatment for 6 months. The effects of daily consumption of honey on IR, serum concentration of several inflammatory biomarkers, and body fatness will be evaluated. The results of this study would reveal the antidiabetic effect of the bioactive compounds in honey in insulin-resistant obese women.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 19-45 years
* Obese (BMI \>= 30 kg/m\^2)
* Premenopausal

Exclusion Criteria:

* Individual who use any drug or supplements known to affect lipid, glucose for at least the last three months.
* Individual who previous insulin treatment
* Smokers
* Individual who have diabetes, kidney, liver, or hormonal diseases
* Individual who have significant weight changes \> 5% during the past 6 months
* Women who are postmenopausal
Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Hypotheses:

H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls.

H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification.

H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification

This study is a prospective, randomized, controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
2. Extremity Wound ≥75cm2 requiring operative intervention
3. Minimal age of 18 years

Exclusion Criteria:

The following co-morbidities will result in exclusion from study:

1. Coronary Artery Disease,
2. Diabetes Mellitus (IDDM or T2DM),
3. Peripheral Vascular Disease,
4. Age \>65,
5. Connective tissue disorders,
6. Immunosuppression,
7. Clinically-evident peptic ulcer disease,
8. Substantial renal dysfunction (as assessed by a serum creatinine \>1.5 or calculated creatinine clearance of \<50),
9. Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,
10. Severe penetrating or hemorrhagic traumatic brain injury,
11. Endoscopic gastrointestinal interventions,
12. Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
13. Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
14. History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
15. Hepatic Impairment
16. Warfarin
17. Lithium
18. Drugs known to inhibit CYP2C9 Liver Enzymes
19. Subjects known or suspected to be poor CYP2C9 metabolizers
20. Concomitant use with ACE Inhibitors and Angiotension II Antagonists
Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA

To facilitate the early gastric cancer diagnosis, an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free (cfDNA) will be developed and validated.

Cancer-related features in cell-free DNA (cfDNA) fragments have gradually been identified and play essential roles for non-invasive early cancer detection. Integrated analysis of several cfDNA features have proven to achieve enhanced detection sensitivity as compared to single feature.

This study aims to develop and validate a novel blood-based whole methylome sequencing followed with a multi-dimensional model to analyze several features of cfDNA for GC early detection. Specifically, blood samples will be prospectively collected before gastroscopy. Cases and controls will be randomly divided into a training and a testing dataset at a ratio of 2:1. Plasma cfDNA will be isolated and extracted, followed with a bisulfite-free low-depth whole methylome sequencing. A multi-dimensional model named THorough Epigenetic Marker Integration Solution (THEMIS) including methylation, fragmentation, and chromosomal copy number alternation will be constructed in the training dataset. The performance of the model in differentiating cancer patients from non-cancer controls will then be evaluated in the testing dataset.

Eligibility Criteria:
Inclusion Criteria:

1. Complete clinical info;
2. Patients self-agree to join the study and with signed patient consent and good compliance.

The specific inclusion criteria for subjects to be included in the malignant group:

1. According to the definition of AJCC's 8th Edition Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology and with pathological stages of stage I-IV, including patients with esophageal gastric junction adenocarcinoma (EGJ);
2. Has not previously received any local or systematic anti-tumor treatment.

Exclusion Criteria:

1. Diagnosed previously with any kind of malignant tumor;
2. Have received total or partial gastrectomy;
3. Have received bone marrow or organ transplantation;
4. Have received blood transfusion in the past 6 months;
5. Incomplete clinical info or unqualified to participate in the study.
Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy

The main aim of this study was to analysed the security of a supervised exercise program on maternal cardiovascular system and assess the positive effects of this program on maternal cardiovascular function and structure

During pregnancy, the effectiveness of cardiovascular system is necessary to the growth and development of the baby, however many changes in it occur during this period.

Physical exercise has shown to have a positive effect on cardiovascular structure and function in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Fuenlabrada and Hospital Universitario Severo Ochoa (Madrid).

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program
* Younger than 18 years old
Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)

The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs.

This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an Institution Review Board-approved informed consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Implanted with study IOLs in both eyes at least 4 months prior to study participation;
* BCDVA of 0 logMAR or better in each eye.

Exclusion Criteria:

* Residual astigmatism greater than or equal to 1.00 D;
* Clinically significant ocular conditions as specified in the protocol;
* History of ocular surgeries other than limbal relaxing incisions
* Other protocol-specified exclusion criteria may apply.
Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children

Background:

Bronchial hyper responsiveness (BHR) assessed by methacholine challenge test (MCT) may aid in the diagnosis of asthma, while negative MCT can help to exclude the diagnosis. Laboratory measures that predict the results of MCT are expected to reduce the number of procedures. The possible capacity of High sensitive C-reactive protein (hs-CRP), a marker of systemic inflammation, to predict negative or positive MCT in children has not been evaluated.

Aim: to evaluate the capacity of hs-CRP to predict positive or negative MCT in school aged children and to compare it with markers of airway inflammation: Fractional exhaled Nitric Oxide (FeNO) and markers of allergic sensitization (IgE and peripheral blood eosinophils).

Design: Prospective study evaluating these parameters in patients with positive and negative MCT.

Participant selection: The study population included subjects (age range 6 to 18 years) referred for Methacholine Challenge Test (MCT)

Sample size: 130 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, methacholine challenge test with determination of PC20(the provocative concentration that reduced FEV1 by 20% from baseline), exhaled nitric oxide (eNO). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, hs-CRP. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits.

Primary end point: hs-CRP levels as add on tool to predict negative or positive MCT in children Secondary outcome parameters: All other parameters are the secondary end points.


Eligibility Criteria:
Inclusion Criteria:

* Age range 6 to 18 years
* Patient referred for Methacholine Challenge Test (MCT)

Exclusion Criteria:

* Base line FEV1(forced expiratory volume in the first second) \< 65%
* The presence of other systemic or lung disease
* Anti-inflammatory drugs
* Upper respiratory tract infection in the last month