cyrilzakka/clinical-trials huggingface dataset:
Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients

The purpose of this cross-sectional, multicenter study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients who attend to sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and asthma control, will also be studied.

To determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients attending their routine clinical visit at sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and the status of asthma control, will also be studied. It is expected that this study will contribute to the understanding of severe asthma, ultimately helping to inform therapeutic decisions and addressing patients' needs.

Eligibility Criteria:
Inclusion Criteria

Patients must fulfil all of the following inclusion criteria to be included in the study:

* Male or female patient, aged 12 years or older by the time of study entry
* Patient visiting a participating center for a routine clinical appointment
* Patient is willing and able to provide a blood sample for IgE and eosinophil levels determination as part of their routine clinical visit
* Diagnosis of severe asthma for at least one year as defined by:
* Treatment with guidelines-suggested medications for Global Initiative for Asthma (3) steps 4-5 asthma
* Patients or their legal guardian, who voluntarily sign and date the informed consent form prior to study entry.

Exclusion Criteria

* Patients with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory condition beyond severe asthma
* An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study Patients who are currently under a biologic therapy to treat their severe asthma
Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise

The study aim is to monitor, during exercise tests carried out in various conditions, the alveolar dead space, by means of continuous transcutaneous measurement of Pt CO2, which would be used as a surrogate for arterial PaCO2. Validity of this measurement needs to be assessed against arterial sampling (either arterial, or arterialized capillary), especially with regards to the lag time required by the CO2 diffusion from the arterial compartment (PaCO2) to the cutaneous one (PtCO2), in particular when rapid changes of CO2 might be induced by exercise.

The evaluation will be done in 2 different settings:

* intensive care patients, equipped, for their routine clinical care, with an arterial line; this allows for a precise timed comparison between PaCO2 and PtCO2 readouts;
* routine exercise test, where blood gas evaluation is done essentially by means of arterialized earlobe capillary sampling.

Following assessment of validity of the measurement (and the lag time PaCO2-PtCO2 which might be necessary to introduce as a correction), evolution of dead space during excise test will be tested in different conditions: Healthy subjects, patients with Chronic Obstructive Pulmonary Disease (COPD), chronic heart failure (CHF), hyperventilation, Pulmonary artery hypertension (PAH), or interstitial lung disease (ILD)


Eligibility Criteria:
Inclusion Criteria:

* Written and informed consent, and assent where required.
* Either:

Patients in intensive care, conscious and in stable hemodynamic condition, who are already equipped with an arterial line for blood gas analysis (as required by the routine practice in intensive care; no arterial line shall be inserted for the purpose of this study) (Part A1)

Or patients/subjects scheduled for routine cardio-pulmonary exercise testing. Among these, the following patients will be included: COPD, PAH, healthy subjects, hyperventilation, chronic cardiac failure, interstitial lung diseases (ILD) (Part A2 and Part B)

Exclusion Criteria:

* Non-French speaking patients/subjects
* Unstable hemodynamics
* Local cutaneous lesion or infection
* Arterial disease such as fistula
* Women with the following condition: pregnancy, breast feeding
* Persons deprived of liberty (according to article L1121-5 to L1121-8 of the French Public Health Code)
Study on the Risks of Symptomatic Dengue on Pregnancy

Dengue fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. This public health problem is also becoming European due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of dengue in Europe. Studies on the consequences of dengue fever on pregnancy find contradictory results. In fact, most of these studies are observational studies describing the risk of dengue fever for pregnancy, without comparison with a control group or comparing the different pregnancy morbidities to those found during pregnancy in the general population. Other research is retrospective case-control studies with major biases in the definitions of obstetric complications, which makes the results questionable.

The study therefore proposes to carry out a prospective case-control study with rigorous matching criteria, strict definitions of cases, controls and obstetric complications.


Eligibility Criteria:
Inclusion Criteria for the case :

* Pregnant patients
* Major
* Affiliated with social security
* Symptomatic or pauci-symptomatic dengue
* Biological confirmation of dengue fever

Inclusion Criteria for the control :

* Pregnant patients
* Major
* Affiliated with social security
* Asymptomatic

Exclusion Criteria for the 2 group :

* Multiple pregnancy
* Patient's refusal
* Protected persons: person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators)
Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.

Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.

Eligibility Criteria:
Inclusion Criteria:

* allogenic BMT from related or unrelated donor

Exclusion Criteria:

* Severe infection
* Relapse
* admission to ICU
* refusal of research
* patients with graft failure
Digital vs. Printed Photographs: Impact on Skin Self-Examinations

The primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. The ease-of-use and overall satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be evaluated. The study involves patients in the Pigmented Lesion Clinic that have received total body photography for skin monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the Penn Dermatology Pigmented Lesion Clinic who have a mobile device for personal use that either:
* (1) already have total body photography images, have a compact disc (CD) of digital versions of these images, and who do NOT already conduct proper monthly skin exams at home, and
* (2) patients that are having new images taken

Exclusion Criteria:

* Patients that are children or adolescents
* Patients that are court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
* Patients that are incompetent to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Oral Glucose Tolerance Testing (OGTT) on Patients Taking Somatostatin Analogs

The purpose of this study is to test the effect of long-acting somatostatin analog medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in comparison to healthy controls who are not receiving the medication in order to see whether or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH responses in non-acromegaly subjects taking somatostatin analog treatment, the relative contribution of the medication and the underlying disease state can be analyzed.

Subjects will be informed of the study and after providing written informed consent, subjects will be asked to undergo a 2-hour oral glucose tolerance test (ingestion of 75g glucose with subsequent timed assessment of growth hormone, glucose, insulin and related binding proteins.) Baseline assessment of hormones that may contribute to the results will be drawn, prior to performing the test. Patients will be asked to complete one visit total to participate in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acromegaly or carcinoid syndrome
* Treatment with somatostatin analog therapy (must have established a stable dose of three or more injections on the same dose prior to study enrollment)
* Healthy control subjects

Exclusion Criteria:

* Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
* Use of medication for the treatment of insulin resistance or diabetes
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.

This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Smoker of at least 10 cigarettes daily
* Motivated to quit smoking
* Reports at least one unsuccessful attempt to quit in the last 2 years
* In generally good health
* Provides written informed consent to participate in the sudy

Exclusion Criteria:

* Pregnant or nursing females.
* Women of child-bearing potential must agree to use acceptable contraceptive precautions (contraceptive pill and one barrier method)during the study and for 2-months thereafter
* History of anaphylaxis
* History of alcohol or drug abuse
* History of or current significant medical or psychiatric disorder
* History or presence of cataract or abnormality identified by slit lamp investigation
* Use of other MAO inhibitors, pethidine, SSRIs, tricyclic antidepressants,nasal or oral decongestants or cold medicines containing ephedrine, pseudoephedrine or other sympathomimetics.
* Any medicine contraindicated for use with MAO inhibitors.
* Have or be a carrier of hepatitis B or c or HIV 1 or 2
* Use of tobacco products other than cigarettes
* Use of nicotine replacement therapy in the past month
* Received an investigational drug in the past 30 days
* Previous participation in a study with a MAO-B inhibitor
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs

Safety and Efficacy Study in pediatric subjects \<2 years of age who have undergone Brain or Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent those in routine clinical practice. Retrospective enrolment with a prospective blinded read.

The purpose of this study is to retrospectively enroll children younger than 2 years of age who have undergone brain or spine MRI with 0.1 mmol/kg PROHANCE and to gather safety data as well as to collect MR images for a prospective blinded read to evaluate the efficacy of PROHANCE in terms of visualization and enhancing properties.

The study will be conducted in 4-8 sites in the United States and Europe. It is estimated that 120 patients will be enrolled to provide 108 evaluable patients.

Three radiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile will independently evaluate the MRI images. The efficacy analysis will be primarily based on the blinded reader evaluations.

Imaging conditions will represent those in routine clinical practice, inclusive of pre and post-contrast images.

Eligibility Criteria:
Inclusion Criteria:

* Is male or female and was younger than 2 years of age at the time of the MRI with PROHANCE injection at the dose of 0.1 mmol/kg (±25% in volume administered).
* Has demographic information, reason for the ProHance-enhanced MR examination, relevant medical history, final diagnosis, and safety data available.
* Has documented known or highly suspected enhancing disease of CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of PROHANCE contrast agent.
* Has both predose and postdose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to Bracco or designee to be evaluated in a fully blinded read.
* Has complete information on the imaging protocol used for the ProHance-enhanced MR exam including type of exam (brain or spine), MR scanner and field strength (1.0, 1.5 or 3.0 Tesla)
* Has a documented dose of PROHANCE administered for their MRI exam and/or the volume (mL) and weight of the patient available to be used to calculate the exact dose of PROHANCE that was administered.

Exclusion Criteria:

• Exclude a patient from this study if the patient does not fulfill all of the inclusion criteria.
Yoga for Aromatase Inhibitor-associated Joint Pain

The purpose of this study is to determine whether it might be practical and useful to investigate the effectiveness of yoga classes in relieving joint pain associated with the use of a class of medications known as aromatase inhibitors.

The study uses a single-arm design. All study participants will be assigned to an intervention condition in which they participate in group Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes). Study outcomes are assessed: 1) following recruitment but prior to the first yoga class; and 2) within two weeks post-intervention (follow-up). Additionally, a brief assessment of pain will be conducted four weeks and eight weeks after the start of yoga classes.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with stage 0-III breast cancer
* Have completed local and/or adjuvant breast cancer therapy (with the exception of hormonal therapy) at least one month previously
* Are post-menopausal defined as defined as no menses in the past 12 months
* Are currently prescribed an aromatase inhibitor (AI) medication (anastrozole, letrozole, or exemestane) by a Moffitt-affiliated physician
* Report joint pain that started or worsened after initiation of AI medication
* Report worst pain score \> 4 in the preceding week on an 11-point (0-10) numeric rating scale

Exclusion Criteria:

* Have been diagnosed with another form of cancer (except nonmelanoma skin cancer) in the last five years
* Have uncontrolled cardiac disease, pulmonary disease, or infectious disease
* Have physical symptoms or conditions that could make yoga unsafe (i.e., neck injuries, dizziness, shortness of breath, chest pain, or severe nausea)
* Have a body mass index (BMI) \> 40 kg/m\^2 (based on difficulties severly obese individuals may have with engaging in Iyengar yoga poses)
* Have joint pain attributed to inflammatory arthritic conditions (i.e., rheumatoid arthritis, gout, pseudo-gout) per medical record or patient history
* Had surgery within the past 3 months
* Had injections of medication within the last 3 months to joint(s) currently painful
* Are currently using corticosteroids or opioid medications
* Are currently attending yoga classes
* Do not speak or read standard English
* Are scheduled or are planning to discontinue AI medication in the next 16 weeks
* Do not have sufficient access to the Internet to complete study assessments
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.

This study consists of an open-label, single-ascending dose phase, which will identify the dose for evaluation in a cohort expansion. The expansion phase will be open-label to further characterize the activity of Tune-401 on PD parameters and obtain additional safety data.

Eligibility Criteria:
Inclusion Criteria:

* M/F age 18-75, inclusive
* Diagnosed with Chronic Hepatitis B
* On nucleos(t)ide analogue
* HBeAg-negative or positive
* HBsAg \> 500 IU/ml
* HBV DNA \< 90 IU/ml

Exclusion Criteria:

* ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN
* Participants with any evidence or history of liver disease of non-HBV etiology
* Other protocol defined Inclusion/Exclusion criteria may apply
Hormone Deficiency in Heart Failure With Preserved Ejection Fraction

The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.

Consistent data coming from several independent groups have documented the reduced activity of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

Eligibility Criteria:
Inclusion Criteria:

* Male patients of affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
* left ventricle ejection fraction \> 50% or more

Exclusion Criteria:

* severe liver disease
* serum creatinine levels \>2.5 mg/dl
* history of active cancer with life expectancy below 1 year acute coronary syndrome in the previous 6 months
Evaluation of Sedation in Newborns

Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to numerous painful procedures and often dependent on mechanical ventilation. Mechanical ventilation as well as painful conditions require a sufficient analgesia and or an accurately regulated sedation. Newborns incapable of self-report are therefore dependent on the assessment of the infants level of pain and sedation by the treating team.

The aim of this prospective, controlled, observer-blinded clinical trial is to compare the performance of two EEG based methods and a clinical sedation scale to measure the level of sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation between the clinical sedation score (N-PASS), the bispectral index (BIS) and the amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen control patients are enrolled and observed for up to 72h.


Eligibility Criteria:
Inclusion Criteria:

* newborns with a corrected gestational age ≧ 37 and ≦ 44 weeks of gestation

Exclusion Criteria:

* congenital malformations
* chromosomal aberrations
* brain abnormalities
* severe cerebral hemorrhage (grade III-IV)
* cystic periventricular leukomalacia
* infections of the central nervous system
Single-centre Propensity Score-matched Comparison of Laparoscopic Versus Open Pancreatoduodenectomy

Minimally invasive pancreatoduodenectomy is increasingly performed. However, technical challenges and a perceived higher risk of complications has hindered wide adoption of a minimally invasive approach.

This is a retrospective comparison of a prospectively kept database. The investigators compared surgical outcomes and survival after laparoscopic (LPD) versus open pancreatoduodenectomy (OPD). In order to reduce the effect of bias and confounding, baseline characteristics of both groups were matched using propensity score matching.

All pancreatoduodenectomies were retrieved from a prospectively kept database and retrospectively analysed. All procedures were performed in a single supra-regional Belgian centre.

The primary endpoint was the major complication rate, defined by a Clavien-Dindo morbidity classification grade IIIa or higher \[11\]. Secondary endpoints were 90-day mortality rate, length of hospital stay, operative time, blood loss, transfusion requirements and specific pancreatic complications (pancreatic fistula, haemorrhage, and delayed gastric emptying). In addition, overall survival (OS) and disease-free survival (DFS) were analysed in the subgroups of cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of lesion of pancreatic head or peri-ampullary organs

Exclusion Criteria:

* \< 18 years old