cyrilzakka/clinical-trials huggingface dataset:
Telementoring for Emergency Ultrasonography Performed by Emergency Physicians With Low Experience.

1. Purpose

   * This study aims to evaluate the feasibility of iPhone based telementoring for the ultrasonography.
2. Methods

   * Study Design: Prospective observational study
   * Study Setting: Urban academic ED of tertiary care teaching hospital
   * Study period: July, 2014 \~ December, 2014 (six months)
   * Study participants: Of the patients who need to undergo ultrasonography in the ED, those who are agreed to participate in this study are enrolled.
3. We hypothesize that the iPhone based real time tele-diagnosis by remote expert would not be different from the diagnosis via his/her direct ultrasound examination.

* Teleultrasound system

  1. We already developed the telesystem for viewing the ultrasound examinations performed in the emergency department (ED) by using the iPhone display simultaneously at the out of ED.
  2. Remote mentors can view the patient and examiner's hand holding the ultrasound probe while simultaneously viewing the ultrasound image in the same field of ultrasound display
  3. The examiner and the mentor can communicate with each other.
* Procedures:

  1. The residents perform the ultrasonography and the out of ED expert observe the practice by using the iPhone.
  2. While viewing the practice, the mentor can guide the examiner (resident) to manipulate the probe to get the best ultrasound image.
  3. After finishing the practice, the mentor measures the speed of used mobile network using the application of 'BENCHBEE' and records the predesigned registry.
  4. The registry includes the patients' information, the time and date of examination, the type of mobile network (3G, LTE, WiFi and etc.) and the speed of mobile network, used tele-displayer (iPhone, iPad, iPad mini), used probe, performed body organ (cardiac, lung, Hepatobiliary, vascular, genital organ, appendix and intestine including suspected intussusception), the examiner's level of training and the ultrasound experience of the examiner and the mentor.
  5. The mentor records the patient's diagnosis and the problems during this procedure.
  6. The mentor goes to the patient, perform the ultrasonography directly and confirm the patients' diagnosis.
  7. We will investigate the diagnostic accuracy for iPhone-based tele-ultrasonography comparing these diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* the patients who undergo the emergency physician-performed ultrasonography

Exclusion Criteria:

* the failure of examination due to such as patients' severe obesity, a large amount of gas and etc.
* the patients who refuse to participate in this study.
* the patients who need emergency ultrasonography.
Molecular Diagnosis and Prognosis of Severe Pulmonary Infection Immunosuppressed Hosts

Serious pneumonia is a serious inflammation of the lungs caused by various pathogens, resulting in severe bacteraemia or toxemia, which in turn causes blood pressure drop, shock, blurred consciousness, restlessness, delirium and coma, etc., and requires intensive care and treatment in intensive care unit (ICU) because of its seriousness. There is an upward trend in the number of clinically immunosuppressed host patients, including long-term use of glucocorticoids for rheumatoid immune diseases and kidney diseases, tumor chemotherapy, organ transplantation, etc. A huge risk for these patients is the diagnosis and treatment of infections, especially lung infections. We have previously observed a significant increase in mortality from severe pneumonia in immunosuppressed patients, and our recent analysis of 204 patients with novel coronavirus pneumonia found that low lymphatic counts, immunosuppression, etc. were independent risk factors for death in patients. Early diagnosis and timely treatment are the main means to reduce the mortality rate of severe pneumonia. CD55 is an important complement regulatory protein that inhibits C3 and C5 activation by blocking the formation and accelerating the decay of new C3 and C5 convertases, both of which mediate the downstream action of all three complement activation pathways, and CD55 protects host cells from complement attack. Our previous study found that CD55 was significantly elevated in patients with severe pneumonia. Therefore, this project proposes "Early diagnosis of severe pneumonia based on combination of biomarkers with new generation pathogenesis and early clinical manifestations". It is proposed to validate the predictive effects of recently discovered markers such as CD55, HBP and CD64 on severe pneumonia through prospective single-center clinical studies, explore the establishment of new predictive models for early diagnosis of severe pneumonia, and optimize the diagnosis and treatment strategy of severe pneumonia, and provide new ideas for accurate treatment of severe pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* ① Age ≥ 18 years, ≤ 75 years, male or female

  * Patients diagnosed with severe pneumonia ③ Immunosuppressed patients

    * Patient informed consent

Exclusion Criteria:

* ① Pregnant women, lactating women and women who are at risk of pregnancy.

  * Patients with malignant neoplasms that have metastasized extensively and are expected to have a short survival period.

    * Patients with obstructive pneumonia and interstitial fibrosis due to lung tumours.

      * refusal of the patient or the patient's family to participate in the study.

        * Refusal of invasive mechanical ventilation and tracheal intubation by the patient or the patient's family.
Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work.

Investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others.

Participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.


Eligibility Criteria:
Inclusion Criteria:

* Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
* Richmond Agitation Sedation Scale (RASS) between -1 and +1
* Patient at high risk of re-intubation with at least one of the following criteria:

  * Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema)
  * Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease)

Exclusion Criteria:

* Neuromuscular pathology (myasthenia type) preceding hospitalization
* Pregnant or breast-feeding women
* Patient already included in the study
* Protected person (under guardianship or curatorship)
* Person under court protection
* Person not affiliated to a social security scheme
Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, adult, male or female, 18 55 years of age, inclusive, at screening.
2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study.
3. BMI ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
4. Medically healthy with no clinically significant screening results.
5. For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using acceptable birth control methods:
6. Female of non childbearing potential: must have undergone sterilization procedures, at least 6 months prior to the first dose
7. Non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug/placebo.
8. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated
2. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
3. History or presence of alcoholism or drug abuse within the past 2 years
4. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
5. Females with a positive pregnancy test or is lactating.
6. Positive urine cotinine at screening.
7. Positive urine drug or alcohol results at screening
8. Any significant finding on the Columbia Suicidal Severity Rating Scale (C-SSRS)
9. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
10. Unable to refrain from or anticipates the use of any drug (e.g. prescription, recreational, etc.)
11. Donation of blood or significant blood loss within 56 days prior to the first dose.
12. Plasma donation within 7 days prior to the first dose.
13. Participation in another clinical study within 30 days prior to the first dose.
Anatomy and Ultrasound Evaluation for Central Venous Access

The anatomy and ultrasound image of subclavian vein was investigated on cadavers, volunteers and patients, respectively. Structures，approach，position and complications were discussed to improve the success rate and safety of central venous catheterization.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* gender unlimited
* 18.5 \< body mass index (BMI) \< 30
* written consent signed.

Exclusion Criteria:

* abnormality of the infraclavicular region, including infection, deformity,
* history of bone, joint, muscle or neurovascular disease
* history of injury, radiation or invasive procedure
* subjects refused.
Prevention of Falls and Its Consequences in Elderly People

Falls are an important risk factor for fragility fractures. Both are associated with the ageing process and as they rise also increase the risk of mortality, disability and dependency. Interventions to prevent falls have been based on multifactorial approaches but the outcomes have shown little effectiveness. Lately, it is being recommended interventions which foster physical exercise incorporating it to daily life activities. The OTAGO exercise programme is based on easy physical exercises for older adults and has shown cost-effective outcomes for falls prevention and its consequences.

This is a randomized clinical trial carried out in primary care. The study's scope of activity will include ten urban primary care centers. All selected patients with inclusion criteria will receive a geriatric assessment and other required medical treatment. Next, they will be allocated either to an intervention group or control group. The intervention group will be trained for three months according to the OTAGO exercise program (training phase). Followed by a loyalty phase during which they will be monitored quarterly for a year by their assessment team. The control group will be receive normal medical treatment. Falls and fractures will be monitored quarterly in both groups during 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 75 to 89 years at baseline assigned to Primary Care Team and living in the community
* Ranking the Folstein Mini Mental State Examination test
* Expectation of permanence in the area at least 18 months.
* Agree to participate in the study by informed consent, after reading the patient information sheet.

Exclusion Criteria:

* Current participation in another trial or institutional program of guided physical activity.
* Patients with who have had a hip and/or knee operation or major injury or any other intervention in the last 6 months.
* Patients with who are unable to follow an aerobic physical activity program. Patients using assisted mobility devices are not excluded.
* Patients in Home Care Programs or Nursing Homes at baseline or during the training phase.
* Terminal or severe cancer cases.
* Patients disabled prior to or during the study period.
* Have not been visited in reference's Health Center in the last two years (displacement / transfer
* Very advanced dementia that not allows to follow the instructions in the exercise program and nurse's instructions. In case of a caregiver who assume the realization of exercise program and the following of tips, it may be included.
* Displaced, will temporarily shifted (\>2months/year) o will definitively shifted patients of Health Center.
Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments

The project is a prospective, randomized, controlled study. The material BioHPP (High Performance Polymer) is compared with the gold-standard abutment materials titanium and zirconia in terms of peri-implant soft tissue healing.

A total of 60 participants are divided into three groups of 20 persons each. One group receives BioHPP abutments, while the two control groups receive titanium or zirconia abutments.

The patients are provided with closed healing dental implants. After 3 months, following implant exposure and optical impression, the implants are restored with individual abutments.

Follow-up appointments are scheduled at 3, 6, 12, 24, and 36 months after implantation. During these visits, implant healing is assessed based on clinical parameters such as probing depth, plaque index, mean bone level, and bleeding on probing.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* The patients must be between 18 and 99 years old.
* non-smokers, former smokers, or light smokers (fewer than 10 cigarettes per day).
* ASA ( American Society of Anesthesiologists) Class I or II.
* There must be no pregnancy or breastfeeding period.
* the patients must have an edentulous section of up to 3 teeth in the maxillary or mandibular region, where it is possible to place an implant
* no allergy to any of the study-related materials

Exclusion Criteria:

* Patients under 18 or over 99 years old.
* Heavy smokers or former heavy smokers who quit less than five years ago
* Existing pregnancy or breastfeeding period.
* Individuals classified as ASA Class III to V.
* Presence of a polymer allergy.
* Patients with severe systemic diseases, immune deficiencies, or on corticosteroid medication.
* Patients undergoing local radiation or bisphosphonate therapy.
* Patients requiring sinus augmentation or soft tissue augmentation.
* Participation in another dental study
Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection

Background: Several major studies have demonstrated the success of Truvada as pre-exposure prophylaxis (PrEP) in preventing HIV infection.The CDC guidelines recommend PrEP for people who are at elevated risk of HIV including men who have sex with men (MSM) and people who use injection drugs. People who are incarcerated bear a disproportionate of disease burden, including HIV. Furthermore, men who have been involved with the criminal justice system are more likely to engage in risky behaviors following their release, including condomless sex with partners of unknown serostatus, and injection drug use.

The incarceration setting provides a place to engage men who may be at risk of HIV after they are released.

Following release, community clinics, including the STD clinic at The Miriam Hospital (TMH) Immunology Center, that perform routine testing for HIV and other sexually transmitted diseases (STDs) may be ideal settings to engage vulnerable populations in care, including PrEP.

Despite the demonstrated clinical efficacy of PrEP in reducing HIV transmissions, few clinical programs have piloted the use of PrEP in real-world settings, particularly criminal justice settings. Furthermore, studies demonstrate numerous challenges to PrEP uptake and adherence, including a lack of access or discontinuing care. Engaging at risk men in PrEP care before they leave prison and potentially lost to care during the transition may increase uptake, adherence, and retention.

Objective: This study protocol will evaluate a clinical program that aims to prevent new HIV infections among recently-incarcerated men using a once daily dosing of tenofovir/emtricitabine (Truvada) as pre-exposure prophylaxis (PrEP). This protocol presents an overview of the clinical program, which uses standard-of-care clinical practices and Centers for Disease Control and Prevention (CDC) guidelines for prescribing and monitoring PrEP.

Male inmates at the Rhode Island Department of Corrections (RIDOC) will be screened for HIV risk and, if eligible and interested, will be prescribed and given a one-month supply of PrEP shortly before their release, and receive follow up care at The Miriam Hospital (TMH) Immunology Center following their release.


Eligibility Criteria:
Inclusion Criteria:

* Current men committed at the RIDOC (aged 18 and above); HIV negative; meet CDC indications for PrEP use (based on risk criteria before they were sentenced); interested in taking PrEP; and are able to voluntarily consent to be treated will be included

Exclusion Criteria:

* Individuals who are younger than 18 years old; are HIV positive, Hepatitis B Virus positive or have a CrCl\<60; or unable to provide voluntary consent will be excluded.
Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)

The purpose of this study is to evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone.

The duration of treatment is 3.5 months.

Eligibility Criteria:
Inclusion Criteria:

* Japanese ancestry
* Stable high blood pressure defined by the study criteria

Exclusion Criteria:

* Pregnant or nursing
* Significant concurrent kidney, liver, blood, or other disease
* Recent heart attack or heart surgery
* History of stroke, severe hypertension (high blood pressure), significant heart failure or cardiac arrhythmias
* Significant lab abnormalities
* Uncontrolled blood sugar
* History of certain drug allergies
Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation

Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Because ECMO is invasive, appropriate use of antimicrobial agent, analgesic and sedatives is important to promote recovery. However, a large variability in drugs pharmacokinetics is expected in pediatric ECMO patients due to the combination of ECMO, drug characteristics and disease factor. This study aimed to evaluate whether the PK of drugs is influenced by VA-ECMO and to recommend the optimal dosing strategies for proposed drugs in pediatric patients receiving VA-ECMO.


Eligibility Criteria:
Inclusion Criteria:

* \<19 years old
* receiving VA ECMO in Severance Hospital, Yonsei University Health System.
* receiving one of these drugs: vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
* agreed to participate

Exclusion Criteria:

* receiving drugs that could affect study drug's concentration due to drug-drug interaction
A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting

The purpose of this study if to evaluate the effectiveness of prophylactic antibiotics given during surgery in reducing the concentration of bacteria in a burn wound after surgery.

This is a single-blind, randomized, controlled study to assess the effectiveness and safety of prophylactic perioperative administration of antibiotics for the reduction of bacterial concentration in burn wounds. Subjects who meet enrollment criteria will be randomized in a 1:1 ratio to receive either perioperative prophylaxis with intravenous antibiotics or institutional standard of care, consisting of no antibiotic therapy. This with be a single center study.

Following randomization, patients will receive their assigned treatment (antibiotics or standard of care) after induction of anesthesia, no more than one hour prior to incision.

Patients weighing 120 kg or less will receive 2 grams of intravenous cefazolin, with those weighing \> 120 kg receiving 3 grams intravenous cefazolin. Re-dosing will occur every 4 hours that the patient remains in the operating room.

For patients with a documented beta-lactam allergy, Clindamycin 900 mg will be given intravenously with re-dosing every 6 hours that the patient remains in the operating room. Patients with allergies to both agents will be excluded from the study.

Biological samples will be obtained at three primary time-points: intraoperatively, at the time of the initial postoperative dressing take-down (within six hours), and at the time of a single follow up visit (10-28 days postoperatively).

Eligibility Criteria:
Inclusion Criteria:

1. Subject age ≥ 18 years old at the time of consent
2. Burn wound sustained less than 48 hours prior to the time of presentation to MedStar Washington Hospital Center
3. Burn wounds solely due to a thermal mechanism
4. Total body surface area burned ≤ 10%
5. Anticipated to require a single grafting procedure
6. Able to provide informed consent to participate

Exclusion Criteria:

1. Positive pregnancy test in females of child bearing age
2. Antibiotic administration within 30 days prior to admission
3. Known / documented beta lactam allergy and clindamycin allergy
4. Presence of burn wound cellulitis or infection pre-operatively
5. Intraoperative discovery of infection
6. Incarceration
7. Presence of factors that may affect wound healing, per clinician judgment, such as chronic malnutrition and immunocompromised state