cyrilzakka/clinical-trials huggingface dataset:
EUS-FNB With MOSE vs EUS-FNA With ROSE

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources.

In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.

The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 80 years
* Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter

Exclusion Criteria:

* Coagulopathy
* Altered anatomy
* Contraindications for conscious sedation
* Pregnancy
* Those who cannot provide informed consent
Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 66 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
* Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
* Calculated best-corrected visual activity of 0.7 LogMAR or better
* Positive bilateral CAC reaction

Exclusion Criteria:

* Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
* Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
* Any ongoing ocular infection (bacterial, viral or fungal)
Brain and Meditation (BAM) Study

This study is a randomized controlled trial to test the impact of an app-based meditation program on perceived stress and behavioral correlates of stress with known neurobiological correlates. Healthy adult participants between the ages of 25-65 will be enrolled in the study for about 4-5 months.

Participants will be randomized into one of two groups: the intervention group or the waitlist control group. The intervention group will use a mobile health app for four weeks. Participants will complete pre-intervention, weekly, post-intervention, and 3-month follow-up surveys and tasks.

Primary Objective: Test for hypothesized group differences in perceived stress during participation in a 4-week meditation program and at 3-month follow-up.

Secondary Objective: Within the meditation group, determine whether reductions in perceived stress are associated with changes in hippocampal-dependent behavior.

Eligibility Criteria:
Inclusion Criteria:

* Individual can read, write, speak, and understand English
* Able to provide informed consent
* Willing and able to complete all study procedures, including the Healthy Minds Program
* Has access to a smartphone that can download apps from Google Play or the Apple App Store
* US citizen or a permanent US resident (green card holder)

Exclusion Criteria:

* Extensive experience in meditation practice (e.g., regular daily meditation practice for the past 6 months or regular weekly meditation practice for the past 12 months), experience in substantively similar meditation training programs (e.g., attended a meditation retreat or a yoga/body practice retreat with a significant mediation component), or substantial previous use of the Healthy Minds Program app
* Individuals will be excluded if they previously participated in substantively similar research at our Center at the discretion of the investigator due to similar tasks being used in certain studies
* History of psychosis
* History of mania
* Current psychopathology that interferes with study participation
Antalgic Effects of Well-being Treatments in Cancer Care

observational , Monocentric, study to assess antalgic effects of well-being treatment in cancer care.

Contrary to supportive care, well-being care is imperfectly assessed. Well being care (WBC) consist on complementary programs, with no real consensus. Very few studies have rigorously evaluated its benefits

The objective of this study was to evaluate the impact of four well-being treatments (foot reflexology, socio-aesthetics, Sophrology and singing) provided in a healthcare facility

Eligibility Criteria:
Inclusion Criteria:

* all type of cancer treated at the general Hospital of Valence
* patient agree to participate on Well being session: foot reflexology, socio-aesthetics, Sophrology and singing
* Age ≥ 18 years
* Affiliation to a Social security system
* Patient who has given written consent signed before any specific procedure of the protocol

Exclusion Criteria:

* Patient under guardianship, deprived of liberty, safeguard of justice
* Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the scale (at the discretion of the investigator)
* Refusal to participate in research
Effect of Support for Low-Income Mothers of Preterm Infants

Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 34 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.


Eligibility Criteria:
Inclusion Criteria:

* Mother is eligible for Medicaid insurance.
* Has an infant or infants born 24 0/7-34 1/7 weeks gestation.
* Mother's baby is cared for at one of the four enrolling study sites located in Massachusetts or Georgia.
* Mother is eligible to breastfeed (per hospital criteria).

Exclusion Criteria:

* Mother is not English- or Spanish-speaking.
Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS

Biosensors, the Sponsor would like to determine if the Biosensors Microcatheter is safe and effective in treating patients with CTO by assessing a composite of in-hospital cardiac death or myocardial infarction and device success (defined as successfully facilitate placement of a guidewire beyond the occluded coronary segment), respectively.

Prospective, multi-center, open-label single-arm trial designed to enroll 100 patients undergoing attempted CTO-PCI at up to 10 centers in the United Kingdom and N. Ireland. For assessment of efficacy, the ability of the BM to successfully facilitate placement of a guidewire beyond the occluded coronary segment will be assessed. Patients will be followed up until hospital discharge or 7 days post index procedure, whichever comes first. For the assessment of safety, the incidence of in-hospital cardiac death or myocardial infarction will be assessed at hospital discharge or 7 days post index procedure, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged \> 18 years
2. Patient understands and has signed the consent form.
3. Patient has an angiographically documented chronic total occlusion (i.e. estimated to be \>3 months duration) showing distal TIMI 0 flow. Occlusion with absence of antegrade flow through the lesion and with a presumed or documented duration of 3 months.
4. Suitable candidate for non-emergent PCI
5. Left ventricle ejection fraction \> 25%

Exclusion Criteria:

1. Patient unable to give informed consent.
2. Current participation in another study with any investigational drug or device.
3. Known or suspected contrast allergy.
4. in-stent CTO.
5. Planned treatment of a second CTO during the index procedure
6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel or Prasugrel or Ticagrelor).
7. Recent major cerebrovascular event (history of stroke or TIA within 1 month)
8. Renal insufficiency (serum creatinine of \> 200μmol/L)
9. Active gastrointestinal bleeding
10. Active infection or fever that may be due to infection
11. Life expectancy \< 2 years due to other illnesses
12. Significant anaemia (haemoglobin \< 10.0g/L)
13. Severe uncontrolled systemic hypertension (\> 240 mmHg within 1 month of procedure)
14. Severe electrolyte imbalance
15. Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV.
16. Unstable angina requiring emergent PCI or coronary artery bypass graft (CABG)
17. Recent myocardial infarction (MI) (within the past one week)
18. Unwillingness or inability to comply with any protocol requirements
19. Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
20. Extensive prior dissection from a coronary guidewire use
21. Drug abuse or alcoholism.
22. Patients under custodial care.
23. Bleeding diathesis or coagulation disorder
24. Kawasaki's disease or other vasculitis
Displacement Between PVC and Silicon DLT

The purpose of this study is to compare difference of displacement between Polyvinyl Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position from supine to lateral in thoracic surgery.

Lung isolation and differential lung ventilation, resulting in collapse of operative lung and ventilation of non-operating lung (one lung ventilation; OLV) are essential for thoracic surgery in lung, esophagus and thoracic aorta.

DLT, consisted of tracheal and bronchial lumens, is commonly used to perform differential lung ventilation. The correct position of each lumen in trachea and main bronchus is essential for successful OLV. However, DLT displacement occurs commonly while patients are changed position from the supine to the lateral. The deleterious consequences of a malpositioned DLT can be substantial, even life-threatening including severe hypoxemia.

Considering displacement of DLT during position change and surgical traction, previous studies recommended endobronchial cuff of DLT should be positioned at 0.5cm below the tracheal carina when using left-sided DLT. However, it is based on the data from several research conducted by PVC DLT.

These days, Silicon DLT, different in material from PVC DLT, is also widely used in clinical practice. Silicon DLT is different in not only position of ballon but also distance of each lumen. Furthermore,there are no identified studies about the displacement of silicon DLT during patient position change in thoracic surgery.

Therefore, it is necessary to measure the movement of silicon DLT during positional change from supine to lateral for finding the proper positioning of DLT.

The investigators compare the difference of displacement between PVC DLT and silicon DLT distance during positional change from supine to lateral by fiberotic bronchoscope. And the investigators try to find proper position of PVC and silicon DLT, respectively, to perform safe and successful OLV during thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient required differential lung ventilation in elective thoracic surgery American society of Anesthesiologist physical status(ASA PS) 1\~3

Exclusion Criteria:

* emergency surgery, difficult intubation, poor lung function to accomplish OLV during surgery
A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC
* Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
* Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Haven't received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment)
* Availability of adequate tumor material (block or slides)

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
* Have previously completed or withdrawn from this study or any other study investigating LY2875358
* Have a serious concomitant systemic disorder or significant cardiac disease
* Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
* Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
* Have major surgery less than 2 weeks prior to the initiation of study treatment therapy
* Pregnant or lactating women
Cocoa Intake and Muscle Pain Sensation

This experimental randomized, double-blind, and controlled study included fifteen young, healthy, and pain-free men and 15 age-matched women.

It lasted for three visits with at least one-week washout. Pain was experimentally induced, twice at each visit, with intramuscular injections of 0.2 mL hypertonic saline (5%), before and after intake of one of the different chocolate-types; white (30% cocoa-content), milk (34% cocoa-content), dark (70% cocoa-content). Pain duration, pain area, peak pain, and pressure pain threshold were assessed every fifth minute after each injection, between the time-points 5 to 30 min.

Prior to inclusion, all participants underwent an examination in a dental chair. This included a clinical examination of the orofacial region according to the Diagnostic Criteria for temporomandibular disorders (DC/TMD) by a blinded examiner. Participants were also examined regarding their psychosocial status prior to inclusion, this included depression, somatization, anxiety, pain catastrophizing and stress.


Eligibility Criteria:
Inclusion Criteria:

1. good general health
2. age between 18-40 years

Exclusion Criteria:

1. any pain-related diagnosis of TMD or of the orofacial region
2. any headaches
3. a diagnosis of systemic muscular or joint diseases (fibromyalgia or rheumatoid arthritis)
4. whiplash-associated disorders
5. neurological disorders
6. psychiatric disorders
7. any allergy to the substances used
Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.


Eligibility Criteria:
Inclusion Criteria:

* 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization

Exclusion Criteria:

* patients who have neurological disease,
* endocrinological disease,
* airway anomaly, who require positive pressure ventilation
Complications Following Pacemaker Implantation

This study examines possible risk factors with regard to complications following pacemaker implantation.

This study examines possible risk factors with regard to complications following pacemaker implantation. We are using data from The Danish Pacemaker Register.

Eligibility Criteria:
Inclusion Criteria:

* permanent cardiac pacemaker

Exclusion Criteria:none
Randomized Trial of Erythropoietin During Cerebral Malaria

Malaria remains one of the most common life-threatening illnesses in the tropics with a dramatic toll of more than one million deaths each year. A majority of malaria cases are non-complicated and only few evolve towards severe malaria resulting from the combination of parasite-specific virulence factors and host inflammatory responses. Cerebral malaria (CM) kills more than 1 million African children each year. CM carries a fatality rate of about 20% in adults, higher in children, despite timely and adequate chemotherapy. Moreover, the more rapid clearance of parasitaemia with new antimalarial drugs is not associated with improved survival, suggesting the potential interest for adjunctive therapies in the early phase of the disease.

Cerebral malaria leading to seizure and coma is associated with severe intracranial hypertension caused by brain-swelling. Recent imaging and post-mortem findings in adult cerebral malaria have confirmed the presence of diffuse cerebral oedema with thalamic and cerebellar white matter hypoattenuation, diffuse petechial hemorrhages and symmetric ischemic changes involving the thalamus and the cerebellum. However, the nature of the pathogenetic processes leading to cerebral malaria is incompletely understood but mechanisms linking cytokines with endothelial cells activation in the cerebral microvasculature have been recently stressed. The effect of new neuroprotective therapies has not yet been investigated, although the manifestations of cerebral malaria partly share features with neurological stroke or acute non-specific neurological disorders. The hormone erythropoietin (EPO) is probably one of the more enthusiastic drugs in this area.

EPO is as a member of type I cytokine superfamily with multiple functions, including a prominent role for erythropoiesis and neuroprotection. Systematically administered EPO crosses the blood brain barrier via the abundant expression of EPO receptors at brain capillaries, and acts as an anti-apoptotic and cytoprotective cytokine. Moreover, EPO prevents inflammation by inhibiting pro-inflammatory cytokines including TNFα, preserves endothelial cells integrity and prevents blood-brain barrier permeability. We propose a randomized clinical trial to investigate the safety and efficacy of EPO in patients presenting cerebral malaria and hospitalized at Gabriel Toure hospital, Bamako, Mali, to reduce the incidence of premature death in hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

* Children between 6 months and 14 years old
* Severe cerebral malaria due to Plasmodium falciparum
* Coma (Blantyre score \<3)
* Enlightened assessment

Exclusion Criteria:

* Any case of participation refusal
* Presence of another obvious affection being able to explain the state of the patient
* Negative malaria test (thick smear / thin smear)
* Severe anaemia
Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation

An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral ablation.

This is a randomized controlled non-inferiority designed trial.

Follow up:

Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal Atrial Fibrillation (PAF) for at least 6 months with at least 1 symptomatic episode during the previous 6 moths
* Patient must be felt to be candidates for Atrial Fibrillation (AF) ablation based on AF that is symptomatic and refractory or intolerant to at least one class 1 or 3 anti-arrhythmic agent
* Documentation of at least one episode of AF on 12 lead ECG, TTM or Holter monitor within 12 months of randomization in the trial
* Patient must be on continuous anti-coagulation with warfarin (INR 2-3) or fractionated subcutaneous heparin for \>4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesphageal echocardiogram to exclude left atrial thrombus.
* Patient must provide written informed consent to participate in the clinical trial

Exclusion Criteria:

* Contraindications to oral anticoagulants
* History of any previous ablation for AF
* Intracardiac thrombus
* AF due to reversible causes
* Pregnancy
* atriotomy scar (typically, MV or TV repair/replacement, ASD surgery, transplants)(CABG are okay)