cyrilzakka/clinical-trials huggingface dataset:
A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage

Dr. Purdy has developed a novel bronchial blocker device that has multiple applications. In this project, a simulation model of massive pulmonary hemorrhage in an adolescent intubating manikin will be used to compare the novel method against 3 published methods of lung isolation.

Purpose: To compare a novel airway device in a realistic adolescent airway model of massive pulmonary hemorrhage to three standard methods of lung isolation.

Hypothesis: The novel method will be as fast or faster than traditional methods.

Justification: Lung isolation in massive pulmonary hemorrhage is associated with mortality rates as high as 40%. Current methods of lung isolation are challenging and have a number of limitations. The development of this novel device was a response to the limitations of current solutions and could significantly increase the speed and ease of placing a bronchial blocker under these circumstances.

Objectives: (1) To determine the length of time required for successful lung isolation in each of the four methods trialed. (2) To determine the length of time required for intubation in each of the four methods trialed. (3) To describe challenges in each method within the scenario of massive pulmonary hemorrhage. (4) To assess the utility of the model of massive pulmonary hemorrhage in future simulations.

Research Design: We propose a within-subject randomized procedure evaluation study comparing the placement of a novel bronchial blocker with three standard methods of lung isolation in a massive pulmonary hemorrhage simulation.

Analysis: Mixed effects model will be used to test the difference in total time to lung isolation between the novel method and the other three methods, with the subject as the random variable. If normality and homogeneity assumptions of the mixed-effects model are not fulfilled, then the non-parametric Wilcoxon signed-rank test would be used to compare the novel method to each of the other methods. Time constraints are placed on completion of a task, as such, we will complete sensitivity analysis where we include all participants in the analysis compared to excluding those that were unable to complete at least 1 method.

Eligibility Criteria:
Inclusion Criteria:

* Practicing anesthesiologists
* Anesthesia fellows

Exclusion Criteria:

* Those who don't want to participate
Thrombosis Risk Assessment and Clinical Presentation of Covid-19 Pneumonia

Covid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due to infection-associated inflammation and the resulting cytokine storm, are strongly associated with high mortality rates. In this study, the association between thrombosis risk and clinical presentation of Covid-19 is investigated.

The severe acute respiratory distress syndrome related coronavirus-2 (SARS-CoV-2) and its clinical presentation as Coronavirus disease 2019 (COVID-19) was first reported in Wuhan, Hubei, China in December 2019. It has spread rapidly from its origin in Wuhan City to other countries of the world over the last several months.

Although it mainly affects the respiratory system , multiple organ dysfunction and a particularly progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due to infection-associated inflammation and the resulting cytokine storm, are strongly associated with high mortality rates. SARS-CoV-2 infection may also lead to thrombotic disease both in the venous and arterial circulation of patients apart from respiratory system due to excessive inflammation, thrombocyte activation, endothelial malfunction, and stasis.

Investigators have reported that both CHADS2 and CHA2DS2-VASc scores were related to mortality in individuals that had stable coronary angina, acute coronary syndrome, Takotsubo syndrome or sick sinus syndrome, apart from atrial fibrillation . In addition, thrombocyte/lymphocyte (PLT/LYM) and neutrophil/lymphocyte (NEU/LYM) ratios on admission were also related with thromboembolic complications in former studies which found them useful to predict prognosis of acute pulmonary embolism, as being one of the thromboembolic complications of Covid-19.

Investigators suggest that the parameters mentioned above should also be studied in terms of thrombotic complications of Covid-19. Thus they aimed to find out potential associations between markers of prothrombotic or inflammatory conditions and some clinical features of Covid-19 pneumonia cases on admission and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with COVID - 19 pneumonia between March 11 th , 2020 and April 25th, 2020 in the emergency, internal medicine and cardiology outpatient clinics.
* patients diagnosed by pcr testing and computed tomography of the chest

Exclusion Criteria:

* patients below 18 years of age
* patients with an alternative aetiology of pneumonia
Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's

This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Must be on 600mg or less of levodopa therapy for two years or less.
* Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening.

Exclusion Criteria:

* Current or past history of Dyskinesia.
* State of dementia or have a MMSE score \< 26 at screening.
Impact of Antiretroviral Therapy on Cardiac Biomarkers

Cardiovascular risk appears to be linked to some degree with inflammation. HIV medications have been linked with cardiovascular risk. In this study we will be measuring levels of chemicals in the body associated with inflammation before and after starting HIV medications in patients with HIV. We hope to understand what happens to these chemicals once a patient with HIV is started on these medications to understand their role in cardiovascular risk.

With the advent of antiretroviral therapy, death due to opportunistic diseases have seen a major decline among patients with HIV. However, several antiretroviral medications, in particular protease inhibitors (PI), have been associated with increased cardiovascular risk in large cohort studies. The role of inflammation in cardiovascular risk is currently being elucidated. High sensitivity C-reactive protein (hsCRP) has been identified as a strong independent predictor of cardiovascular disease among healthy individuals in several large cohort studies. Other inflammatory biomarkers such as serum amyloid A (SAA) and interleukin-6 (IL-6) have also been correlated with cardiovascular risk. Among patients with HIV, studies have revealed inappropriate immune activation with increased pro-inflammatory cytokines such as IL-6, IL-10, interferon-γ (IFN- γ), and tumor necrosis factor-α (TNF-α). The effects of this immune dysregulation and the impact of antiretroviral therapy on the cytokines and biomarkers associated with cardiovascular risk remain to be delineated.

Objective: Our aims are to characterize the levels of inflammatory biomarkers at the time of antiretroviral initiation, to define the time period over which the biomarkers change and stabilize, and to determine if the type of antiretroviral drug class used has an impact on the rate of alteration of these biomarkers. Given the disparate cardiovascular risk between women and men of similar age groups, we will study the additional impact of gender on these biomarkers. We will also explore whether there is a correlation between change of CD4 T-lymphocyte counts and the response of the biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a CD4 count between 200-400 planning on initiating antiretrovirals.

Exclusion Criteria:

* Pregnancy,
* Recent discontinuation of an antiretroviral within the past 30 days,
* Active intravenous drug use,
* Acute febrile illness with temperature \> 100 F,
* Diagnosis or symptoms of acute infection within the past 30 days,
* Opportunistic infection or surgical procedure within the past 60 days,
* Myocardial infarction within the last 30 days,
* Renal disease (CKD Stages 3-5), and
* Unstable liver disease.
MAGENTUM 1 HeartMate 3 LVAS: A Single Center Prospective Controlled Study (MAGENTUM 1)

The purpose of this study is to obtain single-center safety and feasibility data on patients managed with reduced anti-coagulation, and the incidence of thrombotic and bleeding adverse events associated with the HeartMate 3 LVAS therapy.

Patients with implanted HeartMate 3 device will be bridged with heparin until target International Normalized Ratio (INR) of 2,0 - 3,0 will be reached on anticoagulation therapy with Warfarin. Along with Warfarin, Acetylsalicylic Acid (ASA) will be administered in dose of 100mg per day. Enrollment for the study will take place in 1-6 weeks post implant of HeartMate 3. Low-intensity anticoagulation protocol will be started at 6 weeks after implant. Target INR of 1,5-1,9 will be maintained and ASA will be administered in dose of 100mg per day with adjustments based on VerifyNow testing. Follow up will last for 12 months after HeartMate 3 implantation. Subsequently, the objectives of the study will be analyzed and evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients implanted with HeartMate 3 LVAS irrespective of an indication
* data collection for major thrombophilic mutations including anti-phospholipid syndrome and lupus anticoagulant testing prior to low-intensity protocol anticoagulation initiation has been performed
* patient will be compliant with an anticoagulation management in a judgment of the investigator
* patient in stable condition with anticipated home discharge

Exclusion Criteria:

* absence of an informed consent
* presence of additional MCS e.g. ECMO, RVAD in less than 7 days prior to low- intensity protocol anticoagulation initiation
* known history of major thrombotic event e.g. DVT
* presence of other than biological valve prosthesis in aortic position
* left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant
* hemodynamically significant or symptomatic carotid artery stenosis prior to low-intensity protocol anticoagulation initiation
Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer

RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known whether tumescent mastectomy or standard mastectomy results in less pain in women with breast cancer.

PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.

OBJECTIVES:

Primary

* To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer.

Secondary

* To compare the total time of operation from incision to completion of wound closure.
* To compare the time of operation from first incision to completion of skin flaps.
* To compare the total estimated blood loss.
* To compare the number of days the Jackson-Pratt drain is left in place under skin flaps with wound drainage \> 30 mL/24 hours.
* To compare the incidence of wound complications such as skin necrosis, hematoma, cellulitis, abscess, and seroma between groups.

OUTLINE: Patients are grouped according to which surgeon provided their evaluation and treatment recommendations.

* Group 1: Patients undergo standard mastectomy.
* Group 2: Patients undergo tumescent mastectomy. All patients receive standardized post-operative pain management comprising morphine sulfate for analgesia or an equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a comparable amount of another narcotic/acetaminophen combination) every 6 hours as needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of 1 of the following:

  * Invasive (ductal or lobular) breast cancer
  * In situ (ductal) breast cancer
* Stage 0-III disease
* Localized disease
* Candidate for curative mastectomy and selected mastectomy or modified radical mastectomy for surgical option of treatment at the University of California Davis Medical Center
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* WBC ≥ 1,500/mm\^3
* Platelet count ≥ 90,000/mm\^3
* PT/PTT ≤ upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* No NYHA cardiac disease class III-IV
* Cancer survivors must have undergone potentially curative therapy for all prior malignancies with no evidence of prior malignancy within the last 5 years, except for effectively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix treated by surgery alone, or lobular carcinoma in situ of the breast treated by surgery alone
* Body Mass Index ≤ 40

PRIOR CONCURRENT THERAPY:

* No prior major breast surgery, including breast augmentation or reduction surgery
* No preoperative chemotherapy or radiotherapy
* No concurrent immediate breast reconstruction
* No concurrent bilateral mastectomy
* No concurrent narcotic pain medication
Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation With Extended Patient Enrolment

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens.

The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.

The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 690AD or 690ADY IOLs mono- or binocularly between June 2022 - September 2023.

Data from five visits will be collected:

* Baseline preoperative (maximum 90 days prior to surgery)- retrospective
* IOL implantation Day 0 - retrospective
* Postoperative visit at Day 1 (+/- 0 days) - retrospective
* Postoperative visit at 1 month (+/- 2 weeks) - retrospective
* Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females above 18 years of age;
* Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between June 2022 - September 2023);
* Diagnosis of cataract and/or ametropia (hyperopia, myopia);
* Subject who has signed an informed consent form.
* Patients who have participated in all visits that are subject to retrospective data collection.

Exclusion Criteria:

* Patients who are not targeted to emmetropia.
* Patients with the following condition(s) at the time of the baseline visit:

  * Corneal astigmatism \> 1.0D
  * Uncontrolled diabetic retinopathy
  * Iris neovascularization
  * Congenital eye abnormality
  * Uncontrolled glaucoma
  * Pseudoexfoliation syndrome
  * Amblyopia
  * Uveitis
  * AMD (advanced AMD)
  * Retinal detachment
  * Prior ocular surgery in personal medical history
  * Previous laser treatment
  * Corneal diseases
  * Severe retinal diseases (dystrophy, degeneration)
  * High myopia
  * Inadequate visualization of the fundus on preoperative examination
  * Patients deemed by the clinical investigator because of any systemic disease
  * Pregnancy
  * Eye trauma in medical history
  * Current use of systemic steroids or topical ocular medication
* Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
Elderly Chronic Diseases Online Biometric Analysis Home Living Technology

The elderly or people with disabilities want to remain in their homes even when their health condition has been getting worse.

This project aims to demonstrate that home automation and telemonitoring can lead to develop a home safety environment that could help the elderly and individual with disability live independently in their own home.

In this study, the automation sensors containing devices follow up chronic disease clinical factors to monitor their biometrical parameters and detect any abnormal prodromal disease decompensation via telemonitoring and geriatric expertise.

The purpose of this study is:

* to provide clinical evidence of the effectiveness of automation tools and telemonitoring/expertise for the home support for people at risk of loss of autonomy
* to demonstrate the clinical benefit of combining the automation and telemonitoring and geriatric teleexpertise


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 or more.
* House equipped with home automation
* Having been hospitalized in the year prior to the inclusion for the following conditions : heart failure, chronic obstructive pulmonary disease (COPD ), diabetes, high blood pressure ( hypertension ) , repetitive falls, chronic renal failure , stroke, neurodegenerative diseases , malnutrition (according to criteria HAS)
* Multiple chronic diseases (at least 2 comorbidities) .
* Having given free and informed consent

Exclusion Criteria:

* Life expectancy less than 12 months
* Enrolled in another clinical trial
First in Man Evaluation of Single and Multiple Doses of Oral ATX2417

First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and pharmacokinetic profile. A fasted/fed comparison will also be included in the single ascending dose part of the trial.

The study consists of two parts, A (single ascending dose including fasted/fed comparison) and B (multiple ascending dose). Part B will be conducted after a thorough review by the Sponsor and the Principal Investigator of the data arising from part A.

Part A This will be a randomised, double blind, placebo controlled, parallel group titration of up to seven single dose levels of ATX2417. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. At each dose level, 2 subjects (1 subject will receive ATX2417 and 1 subject will receive placebo) will be dosed on Day 1 and the remaining 6 subjects will be dosed at least 24 hours later. Safety and pharmacokinetic observations will be made. There will be a minimum of two weeks between the first dosing day at each dose level. Safety and ATX2417 pharmacokinetic data will be reviewed prior to each dose escalation and, based on pharmacokinetic data, it is also possible to decrease the dose if the pharmacokinetic profile so indicates. This part will also include an assessment of the effect of a high fat breakfast on the absorption and pharmacokinetic profile of ATX 2417, performed at a dose predicted to be associated with therapeutic plasma concentrations.

Part B Following completion of Part A, and selection of appropriate dose levels, Part B will be performed. This will be a randomised, double blind, placebo controlled, parallel group study of up to two dose levels of ATX2417 given once daily for eight days. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. Safety and pharmacokinetic observations will be made.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects, any racial group
2. Able to comply with the protocol
3. Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)

Exclusion Criteria:

1. A history of gastrointestinal disorder likely to influence drug absorption
2. Receipt of any medication including over the counter preparations and vitamins within 14 days of the first dose of study drug with the exception of paracetamol up to a maximum of 2 g daily
3. Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction
4. A history of drug or alcohol abuse
5. Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)
Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft

Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft.

Extraction of the non restorable tooth, then socket preservation is applied in experimental group using platelet rich fibrin, while in comparative group free gingival graft is applied with socket preservation.

Eligibility Criteria:
Inclusion Criteria:

* Age range 25-50 years.
* Non- restorable teeth indicated for extraction.
* Good oral hygiene.
* Intact facial and lingual plates of bone, without infection or pathosis.
* Adequate apiacl bone for primaru stability

Exclusion Criteria:

* Presence of uncontrolled Systemic disease eg: diabetes, bone disease or the use of medicines that interfere with bone metabolism, history of head and neck radiotherapy.
* Presence of periodontal and/or periapical infection.
* Smokers.
* Non-compliant patients.
* Pregnancy or lactation in females.
* History of head and neck radiotherapy.
Management of Prostate Cancer in Central China

Some recent reports indicate that incidence of prostate cancer is increasing rapidly in China. However, no large-scale survey of prostate cancer has been done in central China, few data are available regarding its management. The investigators aimed to analyze the management of prostate cancer and compare the outcome of patients with such a survey.

The investigators collected data of patients diagnosed with prostate cancer from the 2003 and 2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the log-rank test and Cox proportional hazards model.


Eligibility Criteria:
Inclusion Criteria:

* patients with newly diagnosed prostate cancer were included in the study. Exclusion Criteria:
* Those with a history of prostate cancer who were treated for another disease were excluded from study.