cyrilzakka/clinical-trials huggingface dataset:
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload

This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions.

The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart.

Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.


Eligibility Criteria:
Inclusion criteria:

* Male or female patients, aged 10 years and above, with β-thalassemia major or DBA or sideroblastic anemia on chronic transfusion therapy, having given written consent to participate in the study.
* Patients with cardiac iron as measured by a myocardial T2\* value that is ≥ 6ms but not ≥ 20 ms.
* Patients with a lifetime history of at least 50 units of red cell transfusions, and must be receiving at least ≥10 units/yr of red blood cells transfusions.
* Patients with a left ventricular ejection fraction (LVEF) ≥ 56 % as determined by cardiovascular magnetic resonance (CMR).
* Patients with liver iron content (LIC) value ≥ 3 mg Fe / g dw, as determined by liver MRI.

Exclusion criteria:

* Patients with clinical symptoms of cardiac dysfunction.
* Patients unable to undergo study assessments including MRI
* Patients participating in another clinical trial or receiving an investigational drug.

Other protocol-defined inclusion/exclusion criteria may apply.
Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms

The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for cochlear implantation with the CI532 or CI512 devices
* 18 years of age or older at the time of enrolment
* Normal cochlea anatomy, established via pre-operative Computer Tomography
* Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance Imaging
* Additional handicaps that would prevent participation in evaluations
* Pregnant and breast feeding women, prisoners, or anyone in custody
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure
Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)

Many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. The management of per-operative iron deficiency is a part of the concept of the "Patient Blood Management", which is a concept recommended by health regulatory agencies in many countries. The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients undergoing a scheduled major surgery, applying the French recommendations (determination of ferritinemia and Transferrin Saturation Factor).


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient with scheduled major surgery
* Patient with signed consent

Exclusion Criteria:

* Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or breastfeeding woman
NSAID Treatment in Knee Osteoarthritis

Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.

Certain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients. These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA patients with satisfactory relief of painful osteoarthritic joints.

The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships between proinflammatory cytokines and the clinical status of OA patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also investigated.

not desired

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for the study were:

* older than 50 years and
* had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.

Further inclusion criteria were:

* clinical signs of joint inflammation (warmth, swelling or effusion) and
* a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification

Exclusion Criteria:

* allergy to NSAIDs,
* progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease),
* history of gastrointestinal ulcer or bleeding,
* a hemoglobin concentration lower than 11.5 g/dL,
* renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
* liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).
Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis

Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through pneumococcal immunization.

The purpose of this study is to determine, through serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) titres whether AAV patients who have gone through pneumococcal vaccination are protected against invasive pneumococcal diseases (IPD).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: diagnosis for granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
* Anti-pneumococcal immunization in the past 36 months
* History of anti-pneumococcal vaccination according to French recommendations (simple vaccine schedule with PPV23 or combine vaccine schedule with PCV13 followed by PPV23 8 weeks later)

Exclusion Criteria:

* Known or suspected pregnancy
* Splenectomy
* Patient without social security coverage
* Patient opposal
HAIC Combined With Bevacizumab and Toripalimab for Advanced Hepatocellular Carcinama

This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Bevacizumab, an angiogenesis Inhibitors was effectively used for hepatocelluar carcinama (HCC) therapy. Toripalimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Bevacizumab and Toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility Criteria:
Inclusion Criteria:

1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
2. age between 18 and 75 years;
3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.
4. No previous use of any systemic therapy or recurrent HCC.
5. Child-Pugh class A or B;
6. Eastern Cooperative Group performance status (ECOG) score of 0-2;
7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
8. Prothrombin time ≤18s or international normalized ratio \< 1.7.
9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. Cholangiocellular carcinoma (ICC);
2. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;
3. Accepting ablation or surgery or other system therapy as firt line therapy after diagnose for primary HCC, ablation or system therapy as first line therapy for recurrent HCC.
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. Known history of HIV
7. History of organ allograft
8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Comparison of Enteral Versus Intravenous Potassium Supplementation

Null hypothesis: There is no difference in the efficacy of IVPR and EPR during an episode of hypokalemia.

Alternate Hypothesis: There is a mean difference of 15% in Serum Potassium levels between the two groups.

Objective: To compare the efficacy EPR and IVPR for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/L after potassium replacement)

Hypokalemia is frequently encountered in daily clinical practices of cardiac intensive care unit (CICU). The development of ventricular arrhythmias related to hypokalemia can lead to sudden cardiac death. Thus, potassium replacement therapy is the cornerstone therapy for hypokalemia.Though intravenous potassium replacement (IVPR) in hypokalemia is the preferred route in most intensive care settings, it is associated with known safety risks. Inappropriately administered, IVPR can lead to arrhythmias, cardiac arrest and death 1, 7, 8. Given these risks, IVPR is considered a "high-alert medication" by Institute of Safe Medication practice.

Enteral potassium replacement (EPR), with its superior safety profile may be a better alternative to IVPR. A retrospective review showed that the efficacy of EPR was comparable to IVPR in pediatric patients after congenital heart disease.

The investigators seek to explore this comparison between EPR and IVPR in a randomized prospective trial

Eligibility Criteria:
Inclusion Criteria:

* • All patients undergoing surgical repair/palliation of congenital heart lesion at the Aga Khan University Hospital and admitted to the pediatric cardiac intensive care unit (PCICU) for post-operative management.

  * Serum potassium levels (\<4.39 meq/l) immediate post operatively
  * Patients/parents willing to participate in the study
  * Have a central venous line for IVPR and an arterial line for monitoring and blood draws.
  * Able to tolerate oral or nasogastric administration of medication for EPR.

Exclusion Criteria:

* • Patients with acute renal failure (estimated clearance creatinine - eccr \<50)

  * Patients with paralytic ileus, necrotizing enterocolitis or GI bleeding.
  * Patients with nausea, vomiting or diarrhea prior to randomization. Patients will not be excluded if these symptoms develop during the trial after the initial recruitment. Based on clinical decision the route of potassium supplementation may be changed if these symptoms. Intention to treat analysis will be used for the primary end point.
  * Patient with symptomatic hypokalemia (manifested as a rhythm disturbances).
  * Initial serum K level (post surgery) \< 2.0 mEq
Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes

This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice.

Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.


Eligibility Criteria:
Inclusion Criteria:

* After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria:

* Current treatment with insulin
* Known or suspected allergy to Levemir® or excipients
* Children below the age of 6 years
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)
Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea

Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA.

The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.

The primary objective of this study is to determine whether sleeping with the novel device (Wave sleep surface) reduces the AHI in those with supine position-related OSA, also known as positional OSA. A secondary aim is to determine the effects of the sleep surface on subjective and objective measures of sleep in patients with positional OSA.

Eligibility Criteria:
Inclusion Criteria:

We will recruit subjects who are:

* 18 years of age and above
* Willing and able to give informed consent
* Prior sleep study done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care and performed no more than 12 months prior to enrollment that meets the following:

  * overall AHI 5-30 events/hr
  * at least 20 minutes of recorded sleep in the supine and nonsupine postures
  * positional OSA defined as \> 50% reduction in the AHI between the supine and nonsupine postures and AHI \< 5hr in the nonsupine position
  * central apneas \< 50% of the total number of apneas and hypopneas
* Patients who meet the above criteria who have been prescribed CPAP therapy but are non-compliant will be enrolled in the study. CPAP noncompliance will be defined as average nightly use \< 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation of CPAP use.

Exclusion Criteria:

* Incapable of giving informed consent
* Under the age of 18
* Known inability to sleep in the lateral position
* Active titration of medication
* Excessive alcohol consumption

  * Excessive alcohol use is defined as:
  * More than 3 glasses of wine a day
  * More than 3 beers a day
  * More than 60 mL of hard liquor a day
* Room air oxyhemoglobin saturation \< 88%
* Use of home oxygen
* Compliant with OSA therapy
* Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score \> 16 or a prior history of falling asleep while driving
* Unstable medical problem such as uncontrolled hypertension.
* Body Mass Index (BMI) \> 45 kg/m2
Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy

The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
* gastric cancer patient undergoing laparoscopic gastrectomy

Exclusion Criteria:

* ASA physical status Ⅳ
* bradycardia (\< 60 bpm), arrhythmia
* uncompensated heart failure
* hepatic failure (Child-Pugh score B)
* renal failure (eGFR MDRD \< 60 ml/min/1.73m2)
Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education

To assess the value of a dedicated knowledge questionnaire, filled by the patient prior consultation. Indeed, it could allow to target specific shortcomings of patients first, and help the cardiologist to prioritize the other therapeutic education, targeting specifically the information provided.

The main objective is to study the impact of a pre-consultation questionnaire on the knowledge gained by the patient on anticoagulant treatment at the exit of cardiology consultation.

The assumption is that this questionnaire would help educate patients about their shortcomings and educate cardiologists lack of knowledge of his patient.

The secondary objectives are :

* Target specific areas in which patients have the greatest lack of information
* Assess the impact of educational level on information
* Assess the impact of age on information
* Evaluate the satisfaction of the information delivered
* Assess patient anxiety vis-à-vis their treatment
* Evaluate the failure rate of the questionnaire to know the number of patients refusing to participate in the study

Eligibility Criteria:
Inclusion Criteria:

* Patient monitoring Cardiology Consultation at University Hospital of Montpellier, whatever the reason
* Patients on oral anticoagulant therapy (warfarin or AOD) for over a month.

Exclusion Criteria:

* Severe cognitive disorders, making it impossible to understand the patient on therapeutic education.
* Disorders of the important vision.
Effect of a Myopia Prediction System on Myopia Prevention and Control

The global rise in myopia, particularly among children and adolescents in China, underscores the inadequacy of current prevention strategies, indicating that conventional screening and education alone are insufficient to curb the prevalence. Integrating personalized myopia prediction into routine care may enhance risk awareness, promote proactive prevention, and improve adherence to medical advice, ultimately reducing the future burden of high myopia.

A myopia prediction system based on artificial intelligence was previously developed, accurately predicting future high myopia risk using efficient, robust, and easily accessible predictive factors, including age, spherical equivalent, and the annual progression of spherical equivalent. This study aims to conduct a prospective, one-year, cluster randomized controlled clinical trial to investigate the effectiveness of this prediction system in preventing and controlling myopia in school-aged children.


Eligibility Criteria:
Inclusion Criteria:

* The participant and their guardian voluntarily signed the informed consent form
* Has the record of eye refraction examination in the past year
* Aged 9 to 11 years, regardless of gender

Exclusion Criteria:

* High myopia(spherical equivalent ≤ -6.00 D)
* Ocular diseases other than myopia (e.g., strabismus, amblyopia, congenital cataract, juvenile glaucoma, retinal diseases).
* Systemic diseases that may affect vision or visual development (e.g., diabetes or other endocrine disorders, cardiovascular or respiratory diseases, Down syndrome)
Pharmacokinetics Study of Qing'E Pill

This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as psoralen and Isopsoralen will be detected.


Eligibility Criteria:
Inclusion Criteria:

1. Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
2. Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
3. The score of Kupperman index is not less than 15.
4. Patients unused estrogen tablets or progesterone injection in 6 months.
5. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
6. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

1. There is no clinical significance abnormal in physical and laboratory examination.
2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
3. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g/L).
4. Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
5. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
6. People with allergies.
7. People taking other drugs within 14 days before the trail.
8. Patients are participating in other clinical trials within 3 months.
9. Pregnant Women.
10. Alcoholics or smokers (past or smoking).