cyrilzakka/clinical-trials huggingface dataset:
Comparison of Three Scores for Ultrasound Assessment and Monitoring of Pulmonary Aeration

This study is designed to compare three ultrasound-based aeration scores that were previously validated in specific populations, and to assess their correlation with computed tomographic measurement of pulmonary aeration in a population with different pathologies.

Hypothesis: The "Loss of Aeration Score" will be more accurate than a simplified version and another widely used score, the "Lung Ultrasound Score".

Assessment of lung aeration may have a great impact in the management of mechanical ventilation and follow-up of diverse lung pathologies. Computed tomographic scan is the gold standard method of lung aeration measurement but is rarely used because it requires transport of critically ill patients end exposes them to radiations. For these reasons, lung ultrasound would be an attractive alternative. Variants of different ultrasound-based aeration scores have been validated in different specific populations, but there is no comparison study that defines the more accurate score that should be used in a population with different pathologies.

Methods: Patients undergoing a computed tomographic scan for dyspnea or hypoxemia will have a standardized lung ultrasound examination on Day 1. For mechanically ventilated patients only, a lung ultrasound examination will be repeated on Day 2 to 4. End expiratory lung volume will also be measured in mechanically ventilated patients on Day 1 and Day 2 to 4. Lung ultrasound images will be interpreted blindly. Correlation of ultrasound-based aeration scores will be done with lung aeration measured by computed tomographic images.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized or visiting the emergency room
* Will undergo a computed tomographic scan for dyspnea or hypoxemia

Exclusion Criteria:

* Poor echogenicity (morbid obesity, multiple thoracic dressings)
* Contraindications to superior limbs or torso mobilization
Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider chosen dose of IV morphine for the treatment of severe pain in the emergency department.

Study design: Open-label, randomized controlled pilot study.

Objective: The purpose of this pilot study is to determine the analgesic efficacy of intravenous lidocaine versus morphine for the treatment of severe pain in the emergency department (ED).

Study design: Open-label, randomized, controlled pilot trial. Participants: Investigators and research assistants will recruit patients ≥18 years old with severe pain (NRS ≥7) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed and 32 patients will be enrolled.

Intervention: After a trained research assistant obtains written informed consent, eligible participants will be randomized to the intravenous lidocaine or morphine arms of the study. In the intravenous lidocaine arm, patients will receive IV lidocaine (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg). In the morphine arm, the ED provider will choose an appropriate dose of morphine for the patient. At 20 and 40 minutes, the participants will be asked "Would you like additional pain medication?". Participants responding in the affirmative will receive morphine 4 mg IV.

Data collection: The trained research assistant will collect data on the patients' pain scores, side effects, and rescue morphine.

Statistical analysis: Investigators will perform descriptive statistics and compare pain scores and pain relief at each time point with unpaired t-tests.

Eligibility Criteria:
Inclusion Criteria:

* Subject has severe pain (NRS ≥7)
* Subject has anticipated ED stay of ≥1 hour

Exclusion Criteria:

* High acuity trauma patients
* Patients deemed to critically ill by ED provider
* Active psychosis
* Pregnancy
* History of heart block or bradycardia
* Allergy to lidocaine or amide type local anesthetic
* History of seizures
HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies

Over twenty percent of HIV-positive persons in the United States are unaware of their infection, leading the Institute of Medicine to recently urge further work to compare the effectiveness of HIV screening strategies. This study will use a randomized trial to compare several variants of emergency-room-based HIV-testing policies in order to determine how HIV test acceptance rates can be increased. The testing policies will be designed using principles from behavioral economics, varying the choice architecture and offering small monetary incentives. This will be the first study to measure differences in take-up rates across a variety of promising but largely untested approaches within a unified randomized trial. Three defaults will be tested: traditional opt-in (test only those patients who request testing), opt-out (routinely testing unless patients decline), and active-choice testing (patients are required to state whether they want to be tested). The study will also be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up. An additional novel study contribution will be to test the hypothesis that compliance with large requests (accept an HIV test) increases after making a small request or pre-commitment - this "foot in the door" technique has not been previously studied in this setting. The factorial design will permit a direct comparison of all interventions, as well as interactions. The study will contribute a nuanced empirical understanding of how testing protocols from behavioral economics theory affect the effectiveness and efficiency of screening programs in an actual scaled- up setting (San Francisco General Hospital). This will assist in implementing and assessing recent CDC guidelines on HIV screening, while also more generally advancing scientific knowledge related to applying behavioral economics in comparative effectiveness research.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 13 - 64 years who are awake, alert, not intoxicated, and understand the premise of the test will be offered the test and questionnaire according to their treatment group.

Exclusion Criteria:

* Patients who have altered levels of consciousness, are critically ill (e.g., serious trauma), are known to have preexisting HIV diagnosis, or who have been tested for HIV in the past 3 months will be excluded from the study.
* Pregnant patients will be excluded due to alternative guidelines for incorporating opt-out testing during prenatal care.
* Any patients who are in police custody will also be excluded due to their lack of control over study participation decisions and ethical concerns over possible coercion.
Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).

Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a strategy with a maintenance treatment and a conventional strategy without antifungal maintenance therapy.


Eligibility Criteria:
Inclusion Criteria:

All patients with ABPA justifying an attack treatment with corticosteroids and itraconazole and combining the following criteria:

1. atopic subject or a history of asthma , history of total Immunoglobin E (IgE)\> 417 kU / L (or \> 210 kU / L with a clear worsening) of a known ABPA), specific Immunoglobin E against Aspergillus fumigatus positive ( \>0.35 KUA/L) or positive skin tests.
2. associated with two other of the following criteria: documentation of precipitating antibodies or Immunoglobulin G positive to Aspergillus fumigatus, of radiological infiltrates associated with ABPA (transitional / persistent / bronchial dilation), of blood eosinophilia \> 500 elements/mm3.
3. After informing and obtaining consent signed.

Exclusion Criteria:

* Women of childbearing age who do not have an effective contraception for at least 12 first months of the study( 10 months + 2 months of treatment washout) pregnant or lactating women,
* Patient with cystic fibrosis
* Patient with a contra-indication to itraconazole
* Intolerance to β2 -agonists
* Known hypersensitivity to liposomal amphotericin B or any other component
* Laboratory abnormalities: significant abnormalities of platelet blood count , liver function tests (SGPT, SGOT(serum glutamate oxaloacetate transaminase) , total bilirubin \> 5 times the upper limit of the normal range )
* severe renal function impairment (creatinine clearance enf to 30 ml/min)
* Concomitant use of one or more of the following treatments: Alfuzosine, alcaloïdes de l'ergot de seigle vasoconstricteur, aliskiren, astemizole, atorvastatine, avanafil, association Ombitasvir and Paritaprevir, Bepridil, Cisaprid, Dabigatran, dapoxetin, domperidon, dronedaron, Eplerenone, Halofantrin, Ivabradin, Lomitapid, lurasidon, Millepertuis, mizolastin, Pimozid,Quétiapin, quinidin, Ranolazine, ritonavir, Sertindole, sildénafil, simvastatin, sirolimus, Sultoprid, Terfenadine, ticagrelor, triazolam Vardénafil (in men over than 75)
* patient with anti IgE- monoclonal antibody for less than 4 months or with current complications related to previous treatment with anti IgE- monoclonal antibody -
* Ventricular dysfunction demonstrated such as congestive heart failure or a history of congestive heart failure
* Simple aspergilloma, chronic pulmonary aspergillosis, invasive pulmonary aspergillosis
* Respiratory infection aggravating asthma or ABPA
124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome

This clinical trial will use the amyloid-binding radiotracer, 124I-evuzamitide, to potentially detect amyloid, in the heart and elsewhere, in patients who have a history of lumbar spinal stenosis and/or carpal tunnel syndrome.

This is a single center, open label, pilot study using an amyloid-reactive peptide labeled with iodine-124 (124I-evuzamitide) and PET/CT imaging to detect the presence of cardiac and extracardiac amyloid in patients who have undergone surgical intervention for lumbar spinal stenosis (LSS) or carpal tunnel syndrome (CTS) and who have amyloid-positive connective tissue \[ligamentum flavum (LF) in LSS patients or tenosynovium in CTS patients\] assessed at the time of the corrective surgery.

Eligibility Criteria:
Inclusion Criteria:

* Must be ≥ 60 years of age.
* Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
* Must have a Congo red positive ligamentum flavum or tenosynovial specimen analysis after laminectomy or carpal tunnel release surgery that is visually categorized as either "extensive" amyloid load or "mild/moderate" amyloid load by an experienced reviewer.
* Those with mild/moderate amyloid load in the connective tissue who also have a history of at least one other orthopedic clinical manifestation, including, but not limited to, carpal tunnel syndrome, lumbar spinal stenosis, trigger finger, biceps tendon rupture, and shoulder/hip/knee arthroplasty.
* Females must be non-pregnant and non-lactating.

Exclusion Criteria:

* Subjects on dialysis.
* Subjects with a confirmed diagnosis of systemic amyloidosis, other than musculoskeletal tissue.
* Inability or unwillingness to comply with the study requirements.
* Subjects taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.
* Inability to lie still for \~40 minutes on the PET/CT scanner.
* History of iodine (potassium iodide) allergy.
* Other reason that would make the subject inappropriate for entry into this study.
Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies

This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or greater
* Malignancy scheduled to receive etoposide and carboplatin therapy
* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
* Adequate bone marrow, liver, renal function and coagulation status
* Informed consent
* Agree to use birth control through 28 days of last treatment dose
* Pregnancy test for women of child-bearing potential
* No available standard therapy

Exclusion Criteria:

* Allergy to the the study treatment drugs
* Unstable current medical condition
* Presence or history of injury to the urinary tract
* Active infection
* Major surgery within 4 weeks prior to treatment
* Minor surgery within 2 weeks prior to treatment
* Current acute steroid therapy or taper
* Currently pregnant or nursing
* Substance abuse or condition that may interfere with participation
* Received other investigational drugs within 30 days
* Within 4 weeks of their last chemotherapy
Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients

The investigators propose an observational study including patients with inflammatory bowel disease under biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23 (Ustekinumab), followed by an external Gastroenterology consultation at Centro Hospitalar Tondela-Viseu.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of IBD (according to ECCO diagnosis criteria);
* Adult patients (over 18 years);
* Full capability of signing informed consent.

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients submitted to prior biological therapy (only for the IBD-naive group)
ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B

IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

ST-2 is an IL-1 receptor family member and exists in both a membrane-bound isoform and a soluble (sST2) isoform. It has a functional ligand (Interleukin-33) and via ST-2/IL-33 inflammation and immunity is regulated. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic hepatitis B or liver cirrhosis

Exclusion Criteria:

* Accompanying chronic inflammatory disease
Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?

In this study; Among the patients randomized because of severe postoperative sequelae expected as a result of radiological and clinical examinations; nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and therapeutic elastic bandage application considering inflammatory symptoms' severity and health related quality of life following surgical removal of impacted third molars. The study hypothesis was formed stating that corticosteroid injection and elastic bandage application would reduce the inflammatory symptoms more than NSAID.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years
* American Society of Anesthesiologists (ASA) Class 1 physiological status
* Consistent radiological and clinical data
* Volunteered to participate in the study
* Surgical difficulty score above 5 which was determined according to Pederson scale.

Exclusion Criteria:

* Being out of age range
* Analgesic or antibiotic therapy history in last 30 days due to symptoms of related third molar
* Smoking cigarette
* Any pathology associated with impacted third molar
* Active complaints on preoperative examination on the day of surgery
* Immunosuppressed or diagnosed with malignancy
* Diagnosed chronic diseases such as; Diabetes mellitus (DM), hypertension, cerebrovascular event, psychiatric diseases, coagulopathies
* Autoimmune diseases
* If total operation time exceeds 45 minutes
* Patients who could not attend regular follow-up visits
* Allergy to the medications prescribed or utilized in study protocol
* Inconsistent clinical and radiological data
Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid

The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of a hyaluronic acid-based gel, compared to MINSD alone.

A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group (HA) and no-hyaluronic acid group (No-HA).

The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of hyaluronic acid (HA) compared to MINSD alone.

Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of a hyaluronic acid-based gel (HA Group) or MINSD alone (No-HA Group).

Primary outcome will be "Probing Depth" (PD), while the secondary outcomes will be "Clinical Attachment Level" (CAL) gain, "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).

After local anesthesia, in HA group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, a hyaluronic acid-based gel will be applied to the intraosseous periodontal pockets.

In the No-HA group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with periodontitis;
* Age ≥ 18 years old;
* Presence of at least 10 teeth per arch;
* Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
* Presence of at least one intraosseous pocket;
* Single-rooted and multi-rooted teeth.

Exclusion Criteria:

* Patients with systemic diseases;
* Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
* Pregnant or lactating;
* Tobacco smokers (≥ 10 cigarettes per day);
* Multi-rooted teeth with furcation involvement;
* Third molars.
Long-term Follow-up of Health Related Quality of Life in Patients With Acute Coronary Syndrome

This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible associations with their cardiovascular profile and to ii) Linkage these data to multiple electronic healthcare records

Over the last few years the chance of dying from a heart attack in England and Wales has reduced dramatically. Even so, there remain huge differences in mortality between hospitals. For example, up to a third of patients with a heart attack who attend hospitals in England are more likely to die than would be expected. That is, the type of treatment and the risk of death depend upon where a patient lives and which hospital they attend. In part, the variation in death may be due to the services available at the hospital or to factors such as socioeconomic deprivation. It may also relate to other factors such as depression, cardiac rehabilitation, patient experience of hospital care and health quality of life.

Using statistical approaches that include measures of quality of life, we propose to examine data about heart attacks in England and investigate the 'postcode lottery of care'. This research is a long term followup that promote improved patient care. In doing so, different factors affecting cardiac rehabilitation will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.

Eligibility Criteria:
Inclusion Criteria:

* Age\>=18 years, both sexes, acute admission to hospital in England with an ACS, consented to participate in EMMACE3 study

Exclusion Criteria:

* Those in whom follow up would be inappropriate or impractical (for example patients in the terminal stages of an illness or requiring emergency treatment such that the gathering research data is not possible or appropriate.
Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

This clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the Sleep Coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors.

Difficulty sleeping, falling and/or staying asleep, is common in people after they have been diagnosed and treated for cancer. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered to be the preferred treatment but until now, there has been limited access for most people to CBT-I because it has required an in-person visit with a trained therapist. This research study is to test a mobile CBT-I app called MI Sleep Coach to deliver CBT-I. The goal of this study is to understand if people are willing to use the app, if they find it useful in helping with sleep difficulty and if they are satisfied with using it. The investigators hope to use information from this small feasibility study to study the effectiveness of the app in a larger group of cancer survivors and ultimately to help cancer survivors with sleep difficulties to sleep better.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Has completed curative-intent treatment (chemo, surgery, RT) for prostate, colon or breast cancer at least three months and not more than 5 years prior to study entry. Note: Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex), Herceptin and maintenance therapies are allowed.
* Ability to read and write English
* Ability to complete questionnaire(s) by themselves or with assistance.
* Reports trouble falling asleep or staying asleep on at least 3 nights per week (most weeks) for the last 3 months.
* Own an Android phone version 8 or higher (The latest version of Android is 11.0) or an iPhone running iOS 11 or higher (The latest version of iOS is 14.3.)
* Ability to provide informed written consent.

Exclusion Criteria:

* Inability to read and write English
* Diagnosis of a sleep disorder other than insomnia (e.g. sleep apnea, restless legs syndrome, narcolepsy)
* Diagnosis of Insomnia prior to cancer diagnosis
* Reports physical symptoms that interfere with sleep, such as shortness of breath, pain, hot flashes, frequent urination
* Major psychiatric or medical condition other than cancer suspected to contribute to their sleep disturbance
* Evidence of active cancer (i.e. not considered NED)
* Currently or previously received CBT-I
* Patients who are night shift workers or subject to other external restrictions on their opportunity to sleep at night.