cyrilzakka/clinical-trials huggingface dataset:
Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant

Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (ELWI) and impaired graft function. PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be life-threatening and can also lead to impaired long term lung function. In ARDS, a restrictive fluid strategy has been associated with an improvement in lung function and outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid management and limiting the extent of ELWI that accumulates in the setting of PGD are lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability index (PPI) represents a novel approach to fluid management, which has been used in patients with ARDS, but to date not in the transplant setting. To determine if these measurements may better guide the management of lung transplant patients, the investigators first wish to establish whether these methods are able to predict the onset of clinical pulmonary edema earlier, whether they correlated with traditional markers of PGD, and whether they may be useful for predicting outcomes.

AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD)

AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and severity of PGD.

AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can predict the onset of PGD.

b) Across different strata of PGD, the investigators will determine whether ELWI and PPI have a differential effect on duration of mechanical ventilation.

The results of the study will be used for the following:

1. Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more discriminatory and have a stronger association with outcome compared to the current gold standard.
2. Provide the means of early identification of those as risk of developing PGD in order to guide management decisions or future therapeutic interventions aimed at preventing or treating PGD.
3. Provide the requisite groundwork for a clinical trial comparing the effects of an ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive bilateral lung transplant recipients

Exclusion Criteria:

* Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements)
* Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)
To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

  1. Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
  2. Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
* Smoking history of at least 10 pack-years

Exclusion Criteria:

* Patients who have had a COPD exacerbation in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 4 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply
Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation.

The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation.

After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification.

After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) \< 0.5mV.

Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance).

The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting \> 30 seconds between day 91 and 365 after the index procedure.


Eligibility Criteria:
Inclusion Criteria:

* • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.

  * Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter
  * Age 18-85 years.
  * Left atrial size \< 55mm.
  * Left ventricular ejection fraction ≥ 45%.
  * Patient is able to provide informed consent and is willing to comply with the study protocol.

Exclusion Criteria:

* Contraindications for repeat ablation
* Reconnected pulmonary veins according to mapping results with a spiral mapping catheter
* Minimal diameter of LAA neck ≥25mm
* History of mitral valve surgery
* Severe mitral valve regurgitation
* Inability to be treated with oral anticoagulation
* Presence of intracardiac thrombi
* Chronic obstructive pulmonary disease treated with long acting bronchodilatators
* Asthma
* Obstructive sleep apnea syndrome
* Pregnancy
* Participation in other clinical studies
* Unwilling to follow the study protocol and to attend follow-up visits
Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
* Mini-Mental State Examination (MMSE) score 16-26

Exclusion Criteria:

* Magnetic Resonance Imaging (MRI) showing other brain abnormalities
* Other diagnosed neurological or psychiatric disorders
Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients

In this study, the effect of nerve blockade and radiofrequency treatment applied to the nerve on pain in chronic migraine patients will be investigated.

Occipital nerve blockade group (control group): Depending on the location of the pain, blockade will be applied unilaterally or bilaterally with 5 cc of 2% prilocaine for each sıde.

Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location with 42 degree, for 240 seconds.

Patients between the ages of 18-60 years, who were resistant to medical treatment and diagnosed with chronic migraine according to ICHD-3 beta criteria (migraine pain for more than 15 days in the last 3 months) who applied to the Neurology and Algology outpatient clinic were included in the study.

All procedures were performed with the patient in the prone position, using anatomical landmarks in the target areas. For Gon Blockade, the target point for the greater occipital nerve was identified along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and one-third of the distance medial to the artery at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, bone contact was obtained using a 25-gauge needle. For Pulse Radiofrequency, the target point for the greater occipital nerve was determined as one third of the distance medial to the artery along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, a 5 cm long 20 gauge radiofrequency needle with a 5 mm active tip was inserted close to the targeted nerve. Sensory and motor electrical stimulation was performed to elicit a compatible paresthesia response in the occipital distribution. Pulsed radiofrequency was applied at 42 degrees C for 240 seconds. Patients were observed after the procedure. Patients were observed before and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-60 years of age diagnosed with chronic migraine according to IHS criteria

Exclusion Criteria:

* Pregnancy
* Major psychiatric disorder
* Bleeding diathesis
* Local infection
* Allergy
Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster

The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.


Eligibility Criteria:
Inclusion Criteria

* Subjects aged 35 to 50 years old
* Subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments and the benefit can be shown by improvements in their global facial aesthetic appearance and satisfaction.
* Subjects with nasolabial folds assessed as mild or moderate.
* Subjects with glabellar lines assessed as moderate or severe, when the severity of the lines has an important psychological impact on the subject.
* Subjects with signed informed consent.

Exclusion Criteria:

* Subjects requiring treatment of forehead lines or crow´s feet.
* Obvious facial sagging (major loss of facial fat/volume).
* Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.
* Heavily scarred or sun-damaged facial skin.
* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated.
* Cancerous or pre-cancerous lesions in the areas to be treated.
* Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months.
* Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months.
* Any aesthetic surgery of the face.
* Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face.
* History of severe keloids and/or hypertrophic scars.
* Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration.
* Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics.
* History of autoimmune diseases.
* Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment).
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs \[NSAIDs\]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
* Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.
* Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.
Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.

Preeclampsia is a serious obstetric condition, affecting 2 to 5% of pregnancies and associated with maternal hypertension and renal dysfunction. It is a constant concern of obstetrical teams in the pre and post partum period. In case of diagnosis in the emergency unit, patients are usually hospitalized. However, in the case of a diagnosis of preeclampsia has been invalidated, but in presence of isolated or frustrated clinical functional signs, in the case of a history of placental vascular pathology, obstetric teams implement surveillance strategies that are binding on the patients.

The sFlt-1/ PlGF assay has a high negative predictive value for the coming week.

The use in clinical practice of these two biomarkers in the indication of negative prediction at one week could help teams in their management but the interest of this use needs to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Pregnant patients term ≥ at 24 weeks of amenorrhoea (SA),
* Management in obstetrical emergencies and at the Centre Hopsitalier Intercommunal (CHI) de Créteil functional exploration center, with prescription of a vascular-renal check-up (BVR) ((proteinuria/creatinuria ratio, blood count, platelets, blood ionogram, creatinemia, transaminases (ASAT, ALAT), haptoglobulinemia, lactate dehydrogenase (LDH), TP).
* Presenting either one of the following isolated or associated clinical parameters:
* HyperTension
* urinary tape proteinuria
* functional signs of hypertension (headaches, phosphenes, accouphènes)
* live osteotendinous reflexes
* epigastric pains
* weight gain, lower limb edema, facial edema
* oliguria
* vomiting
* or one of the following isolated or associated ultrasound parameters:
* fetal hypotrophy, fetal growth deflection
* fetal Doppler abnormalities (umbilical Doppler, cerebral Doppler)
* ooligo-anamnios with intact membranes
* patient who has been informed and has given her oral non-opposition

Exclusion Criteria:

* Diagnosis of preeclampsia
* Refusal of the patient
* Patient whose symptomatology (clinical or paraclinical) leads to a decision to be hospitalized
* Age \< 18 years old
* Non-affiliation to the general social security system
Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 36 months to 83 months;
* Should have complete primary dentition;
* Children must assent to participate and their parents must consent to their participation by signing the consent form.

Exclusion Criteria:

* Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
* Children involved in other research that may impact on this study;
* Families who are expected to move out of the coverage area of study during the first year of enrollment.
Bladder Cancer Case Control Study of Arsenic in Water

This study is examining the relationship between ingested arsenic and bladder cancer in two areas of California where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels.

Water supplies in many parts of the world contain naturally occurring arsenic. Previous studies have shown that arsenic at high doses can cause cancer of the bladder. The risk at lower doses is unknown. This study is examining the relationship between ingested arsenic and bladder cancer in central Nevada and Kings County, California, two areas where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels. Approximately 200 people with bladder cancer and 400 people without bladder cancer will be included. Subjects are interviewed by telephone about past residences, occupations, diet, drinking water consumption, and other lifestyle factors. Arsenic measurements in well water have been collected from the appropriate state agencies and are being matched with residences and drinking water consumption rates to estimate lifetime arsenic exposures for each subject. People with bladder cancer will then be compared to those without to see if people with cancer were more likely to have lived in areas with arsenic in their drinking water.

Eligibility Criteria:
Cases must meet the following criteria:

* Diagnosed with primary bladder cancer from January 1, 1997 until December 31, 2000.
* Live in the following counties at the time of diagnosis: Churchill, Lyon, Mineral, Storey, Douglas, Carson City, Nevada, and Kings County, California
* Ages 20-85 at the time of diagnosis.

Controls will be matched to cases based on gender and five year age groups.
Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

Tobacco use is the leading preventable cause of cancer and cancer deaths in the US. While most (69%) smokers want to quit, only 6% succeed in doing so each year. For many smokers, the addictiveness of nicotine makes quitting very difficult. To reduce cigarette smoking and resulting harms, FDA has announced a comprehensive approach to tobacco and nicotine regulation that includes moving toward a very low nicotine content (VLNC) standard for cigarettes. Greatly reduced nicotine levels would facilitate smoking cessation. However, the maximal success of the policy may require public understanding that, although these new cigarettes are less addictive, their high toxicity and carcinogenicity are unchanged. Yet, nearly half of adult smokers incorrectly think smoking VLNC cigarettes is less harmful than smoking current cigarettes (the VLNC misperception). Additionally, 24% of smokers said they would be less likely to quit if a VLNC regulation is enacted. Thus, the VLNC misperception may partially undermine a nicotine reduction policy. Although communication research suggests it is challenging to change people's incorrect understanding, new communication techniques may help reduce the VLNC misperception. In this randomized trial we will examine whether messages about the harm of VLNC cigarettes can reduce the VLNC misperception and increase intention to quit in a nicotine reduction scenario.

In this study we will assess whether messages about the harm of VLNC cigarettes reduce the misperception that they are less harmful than regular cigarettes.

Recruitment:

We will enroll participants from an existing nationally representative panel.

Informed Consent:

Potential participants are part of an existing nationally representative panel and have already consented to participate in the panel. Before enrolling, participants will also be asked to consent to participate in this study via a consent form included in the study survey.

Randomization:

Survey software will randomly allocate participants to one of the four arms of the study (3 intervention arms or a control arm). Each study arm will have approximately the same number of participants.

Assessment:

Participants will complete a 15-minute survey. The survey will begin with an introduction to the concept of VLNC cigarettes. Then participants will be shown intervention or control messages, and their beliefs will be assessed.

Detailed Description of the Intervention:

Participants will be shown a set of 3 messages about the harms of VLNC cigarettes (intervention arms) or about littering (control arm). Each of the 3 intervention arms use a different theme to attempt to correct the VLNC misperception.

Eligibility Criteria:
Inclusion Criteria:

* Current Cigarette Smoker
* Age 18 or older
* Enrolled in existing nationally representative panel where recruitment is based

Exclusion Criteria:

* None
Symptom Adapted Therapy in GERD Patients

The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients who seek medical advice in primary care for symptoms thought to be GERD-related

Exclusion Criteria:

* Clinical GERD diagnosis/treatment within last 3 month
* History of severe esophagitis (i.e. LA grade C or D)
* Previous anti-reflux surgery
* History of drug abuse
* Female patients who are pregnant or lactating or at risk of pregnancy