cyrilzakka/clinical-trials huggingface dataset:
Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)

This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of achondroplasia/hypochondroplasia
* Patients (and/or Parents legal guardian when required) able to provide informed consent

Exclusion Criteria:

* Absence of diagnosis of achondroplasia/hypochondroplasia
* Patients (and/or Parents legal guardian when required) not able to provide informed consent
Do Endotypes Predict Response and Sequelae in OSA Patients

This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21-65 years old
* Men and women with a physician diagnosis of OSA (or strongly suspected to have sleep apnea - \* see below)
* BMI 20 - 35 kg/m2

Exclusion Criteria:

* Pregnancy (current or planned)
* Nursing
* Inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in English.
* Already on effective therapy and adherent to treatment for OSA
* Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
* Circadian rhythm disorder
* Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
* Uncontrolled hypertension (systolic blood pressure \>160, diastolic blood pressure \>95)
* Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.
* Presence of tracheostomy
* Hospitalization within the past 90 days
* Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (\< 5 years)
* Prior gastric bypass surgery
* Chronic liver disease or end-stage kidney disease
* Active cancer
* Allergy to any of the study drug
* Regular use of medications known to affect control of breathing (opioids, sedatives/hypnotics including benzodiazepines, theophylline)
* Chronically using study drug (Eszopiclone)
* Active illicit substance use
* Alcohol use of \>1 standard drink/night for women or \>2 standard drinks/night for men nightly alcohol use
* Active smoking or vaping within the past 6 months
* Psychiatric disease, other than controlled depression/anxiety
* Prisoners

  * Subjects who are strongly suspected to have sleep apnea will be offered an overnight home sleep apnea test (HSAT) to verify OSA diagnosis.
Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)

The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population.

The secondary objectives are:

1. to assess the level of education and compare it to that of the general population
2. to assess occupational insertion and the educational level according to:

   * The disease (Crohn's disease, ulcerative colitis or unclassified colitis)
   * sex
   * Age at diagnosis (\<or ≥ 10 years)
   * The occurence of surgery, the location of the disease, the treatments undertaken
   * Quality of life
3. Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
4. To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
5. To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)

Chronic inflammatory bowel diseases (IBD) are responsible for high morbidity and impaired quality of life of patients throughout disease course.

Numerous studies have shown the impact of the disease on the quality of life of patients with IBD. However, very little data is available on the level of education and professional integration of patients who started their IBD in childhood.

The hypothesis behind the study project is that the level of education and consequently the professional integration of patients with early pediatric IBD: 1) could be different from those of the general population; 2) and that these differences could be influenced by the nature of IBD, the age of its onset and its main characteristics.

The main objective of this project is to assess the professional integration of these adult patients with pediatric-onset IBD and to compare it with the general population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 25 and over at the time of the study
* Subject listed in the EPIMAD registry suffering from certain or probable Crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerated proctitis, unclassified colitis, diagnosed between 01/01 / 1988 and 12/31/2011, with an age at diagnosis of less than 17 years (definition of the pediatric cohort of the EPIMAD Registry)
* Patient residing in the area of the EPIMAD registry: Nord, Pas-de-Calais, Somme or Seine-Maritime
* Patient not opposed to the research
* Patient not having objected to the use of their data for ancillary studies when registering in the EPIMAD register

Exclusion Criteria:

* None
A Multicenter Study of Artificial Intelligence Model for Fetal Congenital Heart Disease

This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Single or multiple pregnancy;
* Gestational age 16-40 weeks;
* Fetal echocardiographic images are clear and complete;
* Clinical data are complete and detailed;
* Sign informed consent and be able to cooperate with follow-up

Exclusion Criteria:

* Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research;
* Refusal or loss of follow-up
Cerebrospinal Acid-base in Pregnant and Non-pregnant Fertile Women

The third trimester of pregnancy is typically characterized by the development of a marked respiratory alkalosis. The possible role of pregnancy-induced variations of cerebrospinal fluid (CSF) acid-base characteristics on the development of hypocapnic alkalosis is still unknown.

Aim of this study is to characterize, according to Stewart's approach, the acid-base equilibrium of CSF and arterial plasma of pregnant women and compare the results with data obtained from fertile, non-pregnant women.

The reduction in plasma PCO2 correlates with gestational age and was shown to be associated to plasma progesterone concentrations. We hypothesize that pregnancy-related haemodilution, inducing a reduction in CSF Strong Ion Difference (SID), might have a role in the development of pregnancy-related hypocapnic alkalosis.

Samples of CSF and arterial plasma of pregnant women with gestational age \> 35 weeks undergoing spinal anesthesia for elective caesarean section will be analyzed for blood gases, pH, electrolytes, osmolality, albumin and haemoglobin concentration. In addition plasma copeptin levels will be analyzed. The same measurements will be performed in fertile, non-pregnant women undergoing spinal anesthesia for elective surgery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy with gestational age \> 35 weeks
* Scheduled elective cesarean section under spinal anesthesia

Exclusion Criteria:

* known respiratory or neurologic disease
* multiple pregnancies
Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill

GCX damage and its relationship to pharmacodynamics and pharmacokinetics of beta lactam antibiotics in critically ill Hypothesis to be tested: GCX damage impairs pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill patients. There is correlation between GCX damage and insufficient beta lactam levels in patients with commonly used dosing. The aim of the study: Evaluation of relationship between GCX damage and pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill. Type of the study: Observational. Subjects: Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results). Sample size calculation: 20 patients (expected correlation coefficient 0,6, alpha error = 0,05) will lead to power study = 0,89. Intervention: none. Data to be recorded and analyzed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, a presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging will be recorded three times during antibiotic treatment at the time points for blood samples required for pharmacodynamics and pharmacokinetic analysis, microcirculatory data and Perfused Boundary Region.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results).

Exclusion Criteria:

* None.
Comfort Talk (CT) During Outpatient Chemotherapy

Emotional support and physical comfort are two important components of the patient experience at the oncology outpatient clinic. However, current practices do not seem optimal for meeting the psychosocial needs expressed by patients during chemotherapy treatments.

Comfort talk (CT) is a simple, inexpensive intervention that could maximize the feeling of safety and comfort during chemotherapy. Identifying interventions that are interdisciplinary and that can enhance the outpatient patient experience will facilitate access to quality oncology care.

The number of cancer cases requiring chemotherapy is on the rise in North America. About 84% of chemotherapy treatments are administered by nurses in a outpatient clinic context. Although outpatient oncology care are generally associated with a significant improvement in the quality of life in cancer patients, one-third of patients believe that health professionals (including nurses) are not doing everything in their power to comfort or relieve discomfort during chemotherapy treatments. Among the known elements for enhancing the well-being of oncology outpatients, comfort talk (CT) has been found to be very effective. Indeed, CT is a simple and direct form of conversation that is inspired by the principles of clinical hypnosis. While the soothing mechanisms of CT are poorly understood, involvement of cortical regions involved in the modulation of emotions and pain is suggested in several neuroimaging studies.This pilot trial serves as a proof of concept and aims to explore whether CT can be used by nurses to optimize the perception of emotional support and physical comfort during outpatient chemotherapy treatments. To do this, patients enrolled in a chemotherapy treatment cycle will be recruited during a visit to the oncology outpatient clinic. Half of the patients will be assigned to enhanced routine care with an CT intervention and the other half will receive routine care without CT. If there is an overlap between CT mechanisms and those involved in the endogenous control of emotions and pain, a significant interaction of these elements on the well-being of patients during chemotherapy treatments is expected. The results of this pilot trials will be used to justify and prepare for a larger study to evaluate the effects of CT on cancer symptom management and treatment at the outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years of age and older) with cancer (regardless of stage) who have initiated a outpatient chemotherapy treatment cycle for at least 1 week and who are expected to receive at least two additional treatments related to this cycle will be considered for eligibility.

Exclusion Criteria:

* BMI ≥30 or pregnancy;
* With a history of pre-existing chronic pain;
* History of psychosis or serious mental illness;
* Receiving anti-cancer treatments for more than 2 years;
* Any other conditions that make the patient's participation potentially detrimental to his well-being as recommended by the attending physician.
HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy

Hepatitis B virus (HBV) infection remains difficult to eradicate with about 240 million people living with HBV chronic infection. HBsAg clearance, correlated with a good clinical prognosis, is difficult to achieve even with antiviral treatments (3-14 %). HBV envelope proteins are essential for entry into hepatocyte and are targeted by the immune system. Molecular characteristics of HBV envelope proteins may favour better viral fitness at the entry step into hepatocytes and/or HBV escape from host immunity. Here we investigated whether variability of HBV envelope proteins can contribute to the differential responses to anti-HBV treatment in patients with HBsAg clearance or persistence.

Our study is a retrospective study of patients with chronic hepatitis B virus, selected exclusively at the University Hospital Center of Nancy in the Department of Hepato-Gastroenterology (HGE). the patient inclusion criteria were as follows: Adult patients with chronic hepatitis B, treated with nucleos(t)ide analogues, mono-infected with HBV (without co-infection with HCV, HIV and HDV). For each patient included, biological, clinical and therapeutic data were collected retrospectively. Patients with loss of viral load on treatment were included in this study. Among them, patients showed either a clearance of HBsAg on treatment ("responders") or the control patients showed a persistence of HBsAg on treatment ("non-responders", control patients).

Eligibility Criteria:
Inclusion Criteria:

* adults
* patients with chronic hepatitis B
* treated with nucleos(t)ide analogues
* mono-infected with HBV (without co-infection with HCV, HIV and HDV)

Exclusion Criteria:

* minor
* pregnant women
* patients with VHC or VHD
Circulation and Oxygenation Changes of Deep Tissue Respond on LLLT

This study aims to investigate the circulation and oxygenation changes of deep tissue respond on low level light/laser therapy (LLLT) in the healthy population. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to noninvasively monitor hemodynamic indicators of brain and forearm muscle groups, including total hemoglobin (\[tHb\]), and blood flow (BF) and oxygen consumption (VO2).

Low level light/laser therapy (LLLT) employs visible or near-infrared light generated from a laser or light emitting diode (LED) system. It has beneficial effects on a wide range of disease, including improving wound healing, reducing pain, improving memory, treat cancer, and many other human applications. This study aims to investigate the circulation and oxygenation changes of deep tissue respond on low level light/laser therapy (LLLT) in the healthy population. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to noninvasively monitor hemodynamic indicators of brain and forearm muscle groups, including total hemoglobin (\[tHb\]), and blood flow (BF) and oxygen consumption (VO2). Then the investigators concluded the effect of LLLT, according to compare the difference between the experimental group and control group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants with no strenuous exercise or alcohol consumption prior to the test

Exclusion Criteria:

* having risk factors associated with cardiovascular disease
Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib

A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered alone or in combination with Fostamatinib.

An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects when Administered Alone and in Combination with Fostamatinib 100 mg Twice Daily.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent, prior to any study-specific procedures
* Volunteers will be males or females aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2, inclusive.
* Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of first dosing until 2 weeks after the last dosing with IP.
* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non childbearing potential, confirmed at screening .

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP as judged by the Investigator.
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
* Any clinically significant abnormal findings in vital signs as judged by the Investigator
Integrated Novel Clinical Decision Support System (CDSS) in a Computerized Physician Order Entry System

The purpose of this study is to understand the impact of CDSS by knowing the prescribers actions to the CDSS, also the influence of prescribing error announced by pharmacists.

1. To assess the sensitivity of the CDSS which could identify some specific prescribing errors (ex: duplication of drugs, dosage that exceed the maximum dose,prescribes drugs that have drug-drug interactions).
2. To identify what kind of drugs are most likely to cause duplication use by the physicians, and what kind of drugs are most likely to exceed the maximum dosage, also to know what kind of drugs are most likely to cause drug-drug interaction that physicians encounter during prescribing.
3. To evaluate the percentage of physician acceptance of the prescribing errors identify by the CDSS.
4. What's the impact of CDSS on pharmacist announced prescribing error.

Eligibility Criteria:
Inclusion Criteria:

* The prescriptions which induced the alert windows pop out.

Exclusion Criteria:

* The prescriptions which not induced the alert windows pop out.
Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.

The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).

Under subject consent, subjects will have a 12-lead ECG immediately followed by a smartwatch ECG. The heart rhythm and ECG interval measurements will be compared between the 12-lead ECG and smartwatch ECG.

The arrhythmias will include:

* Atrial Fibrillation/Flutter
* Tachycardia
* Bradycardia
* Premature Atrial Contractions
* Premature Ventricular Contractions

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 22 or older, able and willing to participate in the study
* Patient admitted to hospital for ablation, cardioversion, or cardiac electrophysiological exploration.
* Patient who has read the information note and has given their consent before any procedure related to the study.

Exclusion Criteria:

* Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma

This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).

This is a Phase 1b, open-label, non-randomized multicenter study conducted in 2 parts. Part 1, will determine the MTD of the combination of ibrutinib, lenalidomide and DA-EPOCH-R in subjects with DLBCL.

Ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. DA-EPOCH-R will be given at standard doses.

For Part 2, the MTD determined in Part 1 will be the dose used for all subjects. If no MTD is identified, then subjects in Part 2 will be treated with the maximum administered doses (MAD, treatment doses from dose Level 4).

The primary objective for Part 2 is to determine the ORR of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with ABC DLBCL as analyzed by gene expression profiling when treated at recommended phase 2 dose (RP2D).

Eligibility Criteria:
Major inclusion criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
* Pathologically confirmed relapsed/refractory DLBCL
* Subjects must have ≥1 measurable disease site on CT scan (≥ 1.5 cm in longest dimension).
* Adequate hepatic and renal function:

  * AST or ALT ≤2.5 x ULN
  * Serum Creatinine ≤ 2.0 mg/dL and creatinine clearance ≥60 mL/min/1.73
  * Bilirubin ≤1.5 x ULN
* Adequate hematologic function:

  * ANC \>1,000 cells/mm3
  * Platelets ≥75,000 cells/mm3
  * Hemoglobin ≥8.0 g/dL
  * Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be ≤1.5 x the upper limit of the normal range (ULN)
* Must be registered into the Revlimid REMS™program and be willing to comply with the requirements of Revlimid REMS™.

Major Exclusion Criteria:

* Known central nervous system lymphoma
* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks
* Radio- or toxin-immunoconjugates within 10 weeks
* Prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug