cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of luspatercept plus best supportive care (BSC) versus placebo plus BSC in participants who require regular red blood cell transfusions due to β-thalassemia.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to adhere to the study visit schedule (for example, not scheduled to receive hematopoietic stem cell transplantation \[HSCT\]) and other protocol requirements.
* Participant has documented diagnosis of β-thalassemia or Hemoglobin E/β-thalassemia (β-thalassemia with mutation and/or multiplication of alpha (α) globin is allowed).
* Participant is regularly transfused, defined as: 6-25 RBC units in the 24 weeks prior to randomization and no transfusion-free period for \>42 days during that period.
* Participant has Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

Exclusion Criteria:

* Participant has a diagnosis of Hemoglobin S/β-thalassemia or α-thalassemia (for example, Hemoglobin H).
* Participant has active hepatitis C virus (HCV) infection as demonstrated by a positive HCVribonucleic acid (RNA) test of sufficient sensitivity, or active infectious hepatitis B virus (HBV) as demonstrated by the presence of hepatitis B surface antigen (HBsAg) and/or HBVdeoxyribonucleic acid (DNA) positive, or known positive human immunodeficiency virus (HIV).
* Participant has a history of deep venous thrombosis or stroke or thromboembolic events (venous or arterial) requiring medical intervention ≤24 weeks prior to randomization.
* Participant uses chronic anticoagulant therapy, unless the treatment stopped at least 28 days prior to randomization. Anticoagulant therapies used for prophylaxis for surgery or high-risk procedures as well as low-molecular-weight heparin for superficial venous thrombosis and chronic aspirin are allowed.
* Participant who has EMH complications requiring treatment to control the growth of EMH mass(es) during the screening period.
* Participant used immunomodulatory imide drugs (IMiDs) ≤ 24 weeks prior to randomization
Correlation of Chronic Pancreatitis Pathology Features With Endoscopic Ultrasound (EUS) Criteria

In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS) criteria for diagnosing chronic pancreatitis can be correlated with pathologic characteristics of tissues taken from pancreas of patients with suspected chronic pancreatitis.

This will be a retrospective study which will examine results from biopsy specimens and endoscopic ultrasound findings in suspected chronic pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* will include all patients who consented to have both EUS and had biopsy taken for tissue diagnosis.

Exclusion Criteria:

* Will exclude patients who are less than 18 years
One-year Mortality After Surgery and Low Bispectral Index

A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):

* manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
* closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.

Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology patient classification status I, II and III
* patients aged between 50 and 85 years old
* born in France
* surgical procedures lasting more than one hour

Exclusion Criteria:

* American Society of Anesthesiology patient classification status IV
* patients born out of France
* pace-maker
* surgical procedure on the skull or avoiding an adequate positioning of the bispectral index electrode dementia, history of central nervous system disease (tumor, vascular event, Parkinson disease, ...)
* psychiatric illness (severe depression or psychosis), patients receiving a psychotropic treatment
* anesthesia performed during the year before inclusion in this study except for diagnostic procedures
* allergy to propofol, soja, peanuts, or to sufentanil, remifentanil, or morphine, to a myorelaxant or to an excipient,
* hypersensibility to sufentanil, to remifentanil, or to other derivate of fentanyl
ADMA and Mechanical Ventilation in Preterm Infants

The purpose of this study is to study the relation between mechanical ventilation and ADMA concentrations at birth.

Nitric oxide (NO) plays an important role in the normal development and maturation of the lungs. In addition, NO is an important mediator of vascular smooth muscle relaxation, ventilation perfusion matching, neurotransmission and host defence and bacteriostasis. Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS and thereby the bioavailability of NO. Preterm infants have increased concentrations of ADMA. Therefore, inhibition of NO by increased concentrations of ADMA which could be associated with reduced pulmonary functioning.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 32 weeks
* Birth weight \< 1500 gram
* Written informed consent of parents

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal abnormalities
Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)

Prospective, randomized, multicentre, parallel, controlled, and double-blind trial. It is a study with 2 groups with evaluation pre and post treatment with Spinal Cord Stimulation (SCS) implantation of patients with Failed Back Surgery Syndrome (FBSS). The study has been designed to assess primarily non-inferiority and secondarily superiority of SCS DTM therapy

Over 18 years old patients, with leg with or without low back neuropathic pain (DN4 ≥4), previously undergoing low back surgery that, after an Evidence-Based (EB) medical therapy, can be eligible to SCS therapy following the Good Clinical Practice (GCP) guidelines will be implanted of two leads in the epidural thoracic level with at least two poles (Medtronic Vectris) covering the T9-T10 interspace and, if the trial is positive, a Medtronic Intellis Internal Pulse Generators (IPG) will be implanted.

The patients will be randomized to two groups to compare the improvement of pain control, the functional state and the quality of life of the patients by SCS Therapy across 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Leg with/without Low back pain with neuropathic characteristics (VAS ≥ 5 and DN4≥4) during at least 6 months before the screening consultation.
* Stable medical therapy with Evidence Based Medicine (EBM) during at least one month before the screening
* Ready and able to accomplish the procedures of the study and use the activity monitor and the medication diary.
* Have 18 years old or older when the patient signs the informed consent
* Pain kept during at least the last 6 months with VAS ≥ 6 and functional limitation due to the pain
* Refractory to treatment (during at least 3 months), and/or
* Intolerable adverse effects that avoid an optimum medical treatment
* Previous lumbosacral surgery for treatment of the cause of his pain
* Pain attributable to a low back pathology

Exclusion Criteria:

* Pregnant or with planned pregnancy
* Life expectancy \<1 year.
* Polyneuropathy.
* Important Heart disease or peripheral vascular disease
* Degenerative disease that can decrease the functional capacity
* Alcoholism - Drug abuse
* Active infection
* Oncological active disease
* Haematological disorder with increased bleeding risk
* Patient unable to understand / follow the target of the study and the work flow
* When trial period has finished, the negative clinical response will be considered an exclusion criterion. The treatment could be completed, and the data collected but the patient will be excluded of the Randomized Clinical Trial (RCT) and the data analysed separately.
Leucovorin for the Treatment of 5 q Minus Syndrome

The 5 q minus syndrome is a condition that occurs due to a missing segment of chromosome 5 in the normal genetic make-up of the cells responsible for forming blood cells. The condition causes patients to have the inability to make blood normally. Many patients with this syndrome need transfusions of red blood cells, platelets, and/or white blood cells. Low levels of platelets may cause the patient to bleed easily and low levels of whit blood cells make the patient susceptible to infections. A small number of patients with 5 q minus syndrome develop leukemia, which is often untreatable with chemotherapy.

Researchers believe that one of the genes missing in 5 q minus syndrome is the gene responsible for making folic acid active in the body. Folic acid is a vitamin required for normal blood production.

The purpose of this study to test the effectiveness of a drug called leucovorin for the treatment of 5 q minus syndrome. Leucovorin is an active form of the vitamin folic acid that does not require the missing genes to activate it.

Patients participating in this study may or may not improve with leucovorin treatment. However, the study will improve researchers understanding of the disease and may lead other potential therapies for the disease.

The objective of this protocol is to determine whether leucovorin treatment can normalize hematopoietic cell growth and differentiation in patients with 5q- syndrome which may lack the gene for dihydrofolate reductase enzyme.

Eligibility Criteria:
All patients 18 years old and older with RA, RARS and RAEB who have a 5q deletion as their sole cytogenetic abnormality who require transfusion support with blood defined as needing at least one unit of packed red blood cells per month for greater than or equal to 2 months and/or thrombocytopenia defined as a platelet count less than 50,000, and/or severe neutropenia (absolute neutrophil count less than 500) are eligible, including patients that had been treated with chemotherapy or experimental agents such as retinoids, phenylbutyrate, amifostine, Vitamin D, ATG or hematopoietic growth factors.

Patients must not be transforming to acute leukemia (greater than 20% blasts in marrow aspirate).

Patients must not have had treatment with growth factors or any other experimental drug within 4 weeks prior to entry on protocol.

Patients must not have an ECOG performance status greater than 2.

Patients must not have an active uncontrolled infection.

No patients for whom bone marrow transplant is indicated as primary therapy.

Must be able to give informed consent.

Patients must not be HIV positive.

Patients must not be pregnant.
Contributions From the Analysis of Graphs for Identification of Neural Cliques

The aim of the study is to demonstrate that our semantic knowledge (elements of our long-term memory and the process we use them) respond to a graphic organisation and gather together following accurate patterns called cliques (neural networks).

Electroencephalography (EEG) with very High spatial Resolution (HR) (EEG-HR, 256 electrodes) allows for a better understanding of the global and local activity of the cerebral neocortex.

In 2012, following publications by Claude Berrou and Vincent Gripon's Internet, introducing new principles of coding information based on graphical representations in connectionist networks, we approached this team to test biological plausibility of this theory in vivo with EEG.

The central concept is the mental information, defined as all elements of knowledge acquired by the long-term memory on which the reason can build to try to respond to new problems. According to this new theory, these elements of knowledge called qualia or features should be connected within cliques networks. However, we currently do not have graphs comparing methods to measure a good index of both spatial and topological similarity between graphs with high resolution electroencephalography.

For this new study, we propose to combine the strengths of several existing methods of graph comparison which, on top of this, will be especially adapted to the specific context of the analysis of the graphs in the cerebral cortex.

The skills used are diverse: information theory, mathematics, graph theory, computer science, neuropsychology, signal processing and neurology.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Right-handed ;
* French native speaker
* Having given written informed consent

Exclusion Criteria:

* Presence of any psychiatric, neuropsychological and developmental disorder
* Any uncorrected visual impairment
* Any trouble or delay in learning to read / speak french
* Fully bilingual or multilingual
* Medication, treatment and / or substances that may alter or modify brain functions
* Pregnancy, breast feeding
* Persons under major legal protection and/or deprived of liberty

MRI-related criterions

* Cardiac pacemaker or implanted defibrillator
* Iron-magnetic surgical clips
* Cochlear implant
* Intra-ocular or brain foreign bodies
* Less than 4 weeks-old stents, less than 6 weeks-old osteosynthesis materials
* Claustrophobia
Biometry of Occult Lens Subluxation Misdiagnosed as Primary Acute Angle Closed Glaucoma

In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure which were misdiagnosed as primary angle closure at the first visit, and compared with the data of chronic angle closure glaucoma, cataract, primary acute angle closure.


Eligibility Criteria:
ASAC-LS was diagnosed according to the following criteria, including sudden pain in the eye, decreased vision with or without nausea and vomiting. Slit lamp microscopy reveals phacodonesis, lens inclination or vitreous herniation into the anterior chamber, central and peripheral shallow anterior chamber, and asymmetric iris bulge. All patients were confirmed during the surgery to have LS.

APACG was diagnosed with the following criteria6, 7 8, including substantially elevated IOP and closed angle, acute eye pain, blurred vision, or nausea and vomiting. More importantly, ischemic injury caused by acute ocular hypertension, ciliary or mixed congestion, corneal edema, and glaucoma flecks should be detected.

The diagnostic criteria of CPACG included narrow angle with anterior synechiae of varying widths, IOP \> 22 mmHg, and glaucomatous optic disc damage and visual field shrinkage9-11 The angle closure should be more than two quadrants, yet there was no ischemic injury in the anterior segment caused by acute ocular hypertension.

Exclusion criteria were history of laser peripheral iridotomy or peripheral iridectomy, glaucoma filtration surgery, angle closure caused by ocular trauma, uveitis, neovascularization or lens swelling or hyper mature lens. The patients with acute angle closure in both eyes were excluded. The subjects in which Lenstar LS900 examination could not be performed because of severe lens opacity or corneal edema were also not included in the study.
Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma.

PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.

OBJECTIVES:

* Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery.
* Compare results of this regimen in these patients to historical controls.
* Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study.

Patients receive porfimer sodium IV over 5-10 minutes on day 1. Patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3.

Patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignant mesothelioma, including the following cell types:

  * Mixed mesothelial
  * Sarcomatous
* Stage I or II disease using the Butchart system as determined by CT scan or MRI
* Disease confined to 1 hemithorax
* No tumor involvement of esophagus or heart as evidenced by CT scan

  * Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest
  * N2 disease allowed if no contralateral pleural involvement
* No adenocarcinoma or nonmesothelioma sarcoma of the chest wall

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 8.5 g/dL (transfusion allowed)

Hepatic

* Bilirubin less than 3.0 mg/dL
* Alkaline phosphatase less than 2 times upper limit of normal (ULN)
* SGOT less than 2 times ULN

Renal

* Creatinine less than 3.0 mg/dL

Cardiovascular

* No myocardial infarction within the past 6 months

Pulmonary

* Arterial partial pressure of carbon dioxide (pCO_2) less than 50 torr at rest
* Predicted postoperative FEV_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min
* Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation

Other

* Not pregnant
* No other concurrent malignancy except nonmelanoma skin cancer
* No contraindication to general anesthetic
* No history of porphyria
* No indicated sensitivity to porfimer sodium

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 30 days since prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the chest
* No prior radiotherapy for mesothelioma

Surgery

* Not specified
Effect of Prenatal Counseling on Breastfeeding Rates in Twins

Few studies have investigated breastfeeding in twins, and none have addressed the effect of antenatal counseling on breastfeeding twins.The purpose of this study is to investigate the effect of antenatal breastfeeding counseling on the breastfeeding rates in twin pregnancies.

In singleton pregnancies, three randomized studies have recently examined the influence of antenatal breastfeeding education on the breastfeeding rates (Su et al. 2007; Mattar et al. 2007; Wong et al. 2014). Two of these studies did not find differences in the total breastfeeding rates between the groups that received and did not receive antenatal breastfeeding education at the infants' age of 6 months old (Su et al. 2007; Wong et al. 2014). However, Su et al. found higher exclusive breastfeeding rates for 6-months-old infants in the group that received antenatal counseling. In contrast, Mattar et al. 2007 found significantly difference in breastfeeding rates with individual counseling compared to non-counseling or only breastfeeding educational material with no counseling.

Few studies have investigated breastfeeding in twins specifically, and even fewer have focused on the duration of breastfeeding of twin infants. Furthermore, in our literature search, we did not find studies of breastfeeding of twins investigating the effect of antenatal education on breastfeeding twins. Our hypothesis is that mothers of twins receiving specific antenatal counseling on breastfeeding should have a higher rate of breastfeeding than mothers who do not receive antenatal breastfeeding counseling. Therefore, the purpose of this study was to investigate the effect of specific antenatal breastfeeding counseling on the breastfeeding rates in twin pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* twin pregnancies with both fetuses alive between 18 and 34 weeks of gestational age and followed at our twin clinic; absence of absolute contraindications for breastfeeding, such as positive serology for HIV, HTLV; absence of use of lactation inhibitors to treat prolactinoma, such as cabergoline and bromocriptine; and absence of major malformation of one or both twins that could preclude breastfeeding, including gastrointestinal defects, cleft lip and cleft palate, or malformations that would require neonatal surgery with prolonged hospital stay.

Exclusion Criteria:

* fetal or postnatal death of one or both twins; delivery before 32 weeks; major malformation diagnosed postnatal; and lost to follow up or no breastfeeding information.
Augmented Reality (AR) Hong Kong

This is an international, collaborative study evaluating the non-technical skills (NTS) of anesthesiology residents. The goal is to explore the capability of performing a remote, international AR simulation for the purpose of assessing PALS during a medical crisis. Simulation experts in the United States will facilitate the AR simulations with anesthesiology residents in Hong Kong. The medical simulation itself is grounded in traditional best practices in accordance with the American Heart Association.


Eligibility Criteria:
Inclusion Criteria:

* age above 18

Exclusion Criteria:

* a history of severe motion sickness
* currently have nausea, a history of seizures
* wear corrective glasses (they are not compatible with the AR hardware).
Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine

Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine


Eligibility Criteria:
Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Known hypersensitivity to any vaccine products
* Any immunodeficiency, genetic anomaly or severe acute or chronic illness
The Bone Metabolism Characteristics of Premature Ovarian Insufficiency

Explore the bone metabolism characteristics of premature ovarian insufficiency.

Explore the bone metabolism characteristics of premature ovarian insufficiency, indexes includes serum levels of TRACP-5b and BALP, BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck et.al.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed by Western medicine with premature ovarian insufficiency. 18 ≤ patients' age ≤ 39 years;. Patients who voluntarily participate in this study, sign an informed consent form.

Exclusion Criteria:

Patients with congenital gonadal dysplasia or a family history similar to "early menopause".

POI patients with acquired organic lesions or ovarian surgery. Patients who have taken Western or herbal medicine artificial cycle therapy or other endocrine therapy in the past three months.

Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system.

Patients who are breastfeeding or pregnant.
Relative Importance of Cardiovascular Risk Factors and Echocardiographic Parameters Affecting Left Atrial Strain

The goal of this observational study is to learn about left atrial reservoir strain in patients with heart failure with preserved ejection fraction. The main questions it aims to answer are:

* Usefullness of LARS as a predictor of high HFA-PEFF diagnostic algorithm scores (≥5)
* The relative importance of LARS in variables including each component of HFA-PEFF and traditional cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Participants with ICD-10 code of heart failure (I50) from August 2021 to July 2022
* 20-year-old or higher age
* Participants who are available to measure left atrial reservoir strain

Exclusion Criteria:

* Left ventricular ejection fraction \<50%
* Supraventricular arrhythmia (e.g. atrial flutter/fibrillation, atrial tachycardia)
* Participants who are given pacemaker or ICD implantation procedure