cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS

The 2020 pandemic of the coronavirus (SARS-CoV2) has lead to an increase in ARDS cases requiring invasive mechanical ventilation in the ICU (Intensive Care Unit).

The investigators hypothesize that airway pressure release ventilation (APRV) could be beneficial in patients with ARDS secondary to SARS-COV2 viral pneumonia.

Lung protective mechanical ventilation is the cornerstone of ARDS management, reducing the work of respiratory muscles and optimizing gas exchange. However, it can be the source of deleterious effects, grouped under the terms of ventilator induced lung injury (VILI) and ventilator induced diaphragm dysfunction.

The protective ventilatory strategy has led to a significant improvement in the prognosis of ARDS patients, by reducing the volume of the air and oxygen mixture (lower tidal volume) delivered to the lungs and thus reducing the pulmonary stress and strain. However, this protective ventilation usually requires deep sedation and neuromuscular blockade to avoid deleterious patient-ventilator asynchrony.

Airway Pressure Release Ventilation (APRV) has been proposed to reduce patient-ventilator asynchrony and reduce the VILI. The operating principles of APRV are based on the presence of two pressure levels that are kept constant. Spontaneous breathing is possible at any time at both pressure levels if the patient is not deeply sedated or under neuromuscular blockade.

The investigators hypothesize that APRV mode could be beneficial on oxygenation and respiratory work in patients with ARDS secondary to SARS-COV2 viral pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated in Nancy University Hospital between 01/04/2020 and 31/06/2020 for COVID-19 ARDS, requiring invasive ventilation
* Trial of airway pressure release ventilation during the ICU stay

Exclusion Criteria:

* Patients requiring veno-venous ECMO
* Patients unable to complete the 6-hour APRV trial due to poor tolerance : SpO2 decrease \< 90% on FiO2 70%, haemodynamic instability (MAP \< 65mmhg without vasopressors, or 0.5 mg/h increase in norepinephrine, ventilator asynchrony (respiratory rate \>35), hypercapnia (pH \< 7,25 or PaCO2 \>60mmHg)
Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers

This study is intended to define the PCM normal laboratory range.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb)
3. Normal vital signs at screening

Exclusion Criteria:

1. Current daily tobacco use or previous recreational drug use
2. Pregnant or lactating at the time of the study
3. Currently taking any medications known to affect coagulation
4. History of excessive bleeding from minor trauma that required medical attention, spontaneous nose bleeds that required medical attention or multiple spontaneous abortions, liver disease, blood related diseases, congenital or acquired coagulopathies or thromboembolic diseases
5. Current diagnosis of cancer
Peer Motivation Coaches, Social Media-based Support Group, and Behavior Change Strategies to Decrease Prolonged Sitting and Increase Moderate Exercise Snacks

The MOV'D (Move Often eVery Day) intervention is a remotely-delivered, peer-supported intervention that delivers exercise snack (2-5 minutes of moderate to vigorous activity) and behavior change technique (BCT) videos to a private social media support group with the goal of interrupting prolonged sitting at work with MVPA minutes.

The preliminary efficacy, feasibility, and acceptability trial will test the effects of MOV'D, a socially-supported, evidence-based behavior change technique educational and behavioral intervention to increase the number of active hours (an indirect measure of prolonged sitting bouts) (Hypothesis 1) and number of MVPA minutes (Hypothesis 2). This pilot will gather important estimates of the effect sizes, the variance, and covariance of the primary outcomes to calculate the sample size needed to power a larger fully powered RCT.

Prolonged sitting and inadequate moderate to vigorous intensity physical activity (MVPA) are pervasive risk factors for cardiovascular disease (CVD). Recent research has shown that some benefits of moderate to vigorous physical activity can be accrued in motivationally accessible short, 2-5 minute bouts throughout the day rather than needing to be a single, longer, continuous bout. The MOV'D intervention is a novel, remotely-delivered, social-media-based intervention to interrupt prolonged sitting with short bouts of MVPA, compared with a Fitbit-only control. The investigators will randomly assign participants to either MOV'D or a Fitbit only control for one month, with a one-month follow-up, to compare immediate and prolonged effects of treatment on number of workday hours with activity break and number of MVPA minutes.

Eligibility Criteria:
Inclusion Criteria:

* have smartphone with internet capabilities
* spend more than 55% of time sedentary at work
* English literacy
* safe to exercise, assessed by the Physical Activity Readiness Questionnaire (PAR-Q)
* full-time employee at sedentary job

Exclusion Criteria:

-
Evaluation of Proposed EZ2go Complete Bowel Cleansing System

This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).

To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.
* Male and Female participants 18 years of age and older.
* Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.
* Negative urine test at the screening visit.
* Subject is able to read and understand the informed consent form and signs the informed consent form.

Exclusion Criteria:

* Contraindication to any of the bowel preparations being used in the study.
* Unable/unwilling to fill out patient questionnaires following procedure.
* Pregnant or lactating.
* Unwilling to perform indicated lab work.
* Lab results that would indicate stage 4-5 chronic kidney disease (GFR \<30MI/min1.73 m2).
* Personal history of colorectal cancer.
* Personal history of colorectal or small bowel surgery.
* Participants have any condition that, in the investigators opinion, could interfere with the participation and completion of this study.
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice


Eligibility Criteria:
Inclusion Criteria:

* 2 years of age or older
* Body weight of at least 33 pounds
* Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members
* Belong to a household of no more than 6 members, except where additional household members are \< 2 years of age
* Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation
* Female subjects must be:

  * of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or, post-menopausal for at least 2 years) OR,
  * if of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit.

Exclusion Criteria:

* Had treatment for head lice within 14 days prior to Day 0
* Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment
* Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results
* Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment
* Has been using hormonal contraception for less than 3 months or is pregnant or lactating
* Has received systemic corticosteroids within 7 days prior to Day 0 or planned while on study
* Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results
* Has received an investigational agent within 30 days prior to Day 0
CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF

The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail fixation), or tibial plateau open reduction and internal fixation. Secondly, the purpose is to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an ankle fracture open reduction and internal fixation (medial malleolus, lateral malleolus, posterior malleolus, and/or syndesmosis repair), tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation and intramedullary nail fixation), or tibial plateau open reduction and internal fixation
* Patients ages 18-75, inclusive
* Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
* Male patients must be using an effective form of contraception

Exclusion Criteria:

* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Older than 75 years of age
* Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
* History of cannabis abuse or dependence
* History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
* History of stroke or acute coronary syndromes within 3 months before surgery
* Abnormal coagulation profile
* Renal failure (serum creatinine \> 250 μmol/L \[2.83 mg/dL\]) or liver cirrhosis
* Patients that have been on pre-operative opioid management for any reason
* Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
* Patients diagnosed with major depression, psychosis, or substance abuse disorder
* Patients with current or a history of suicidal ideation
* Breastfeeding females
* Patients with clinically significant illness, including cardiovascular disorders
* Clinically significant lab abnormalities
* Abnormal LFTs
* Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
* Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
* Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 concomitantly
* Patients taking strong CYP3A4 and CYP2C19 inducers concomitantly
Phase 1 Study for Safety and Tolerability of EBI-005 Topically Administered to Eyes of Healthy Adult Subjects

This is a First-In-Human (FIH) study to assess the safety and tolerability of ocular administration of EBI-005 in healthy volunteers. Additionally, the PK and immunogenicity of EBI-005 will be assessed.

The planned dose levels are 5 mg/mL EBI-005 (Group 1) and 20 mg/mL EBI-005 (Group 2).

A total of 8 subjects will be dosed in each group with subjects randomized in a ratio of 6:2, EBI-005:placebo. Treatment administration in Group 2 will proceed following a review of safety data from Group 1. In both groups, subjects randomized to active treatment will receive EBI-005 in the right eye and placebo in the left eye. Subjects randomized to placebo will receive placebo in each eye.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and/or females between the ages of 18 and 65 years
* Medically healthy
* Best correction vision of greater than or equal to 20/40 in each eye
* Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to dosing
* Tolerate topical administration to eye
* Signed and dated, Institutional Review Board (IRB) approved informed consent form (ICF) prior to any protocol-specific screening procedures

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic (including sensitive skin on the face), neurological, or psychiatric disease, or any other clinically significant disease not deemed acceptable by the PI
* History of any primary malignancy, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
* Occurrence of active seasonal allergies including ocular allergies (e.g.; annual hay fever)
* Abnormalities following ophthalmological examination: abnormality of the cornea, evidence of ocular inflammation (dry eyes, blepharitis, allergic conjunctivitis, iritis, and uveitis), glaucoma, and optic neuropathy
* Subjects with a history of laser refractive surgery (laser assisted stromal in-situ keratomileusis \[LASIK\], photorefractive keratectomy \[PRK\]), radial keratotomy (RK), corneal transplantation, dry eyes, or radiotherapy to the eyes
* Use of contact lenses currently or within the past one year
* Positive urine drug/alcohol or cotinine testing
The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)

Treatment of stage IV esophageal cancer is traditionally palliative, but treatment response is usually poor. The role of surgery in the treatment of advanced esophageal cancer remains controversial. We sought to determine whether surgical treatment followed by neoadjuvant chemoradiation therapy might provide survival benefits for these patients.

A retrospective review of esophageal cancer patients with M1 disease treated at National Taiwan University Hospital was performed from April 2002 to June 2021. Patient demographics and cancer staging, treatment, and disease recurrence, and time of follow up were included for analysis. Univariate and multivariate analysis was performed for overall survival and progression-free survival analysis. Propensity score matching based on patient age and tumor staging characteristics was also performed for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Stage IV Esophageal Cancer patients
* Patients were treated with chemoradiation therapy (CCRT)

Exclusion Criteria:

* Not Stage IV Esophageal Cancer patients
* Patients were not treated with chemoradiation therapy (CCRT)
A Study to Assess the Effectiveness of an Atrial Fibrillation (AF) Risk Prediction Algorithm and Diagnostic Test in Identifying Patients With AF.

This is a trial to assess the effectiveness of an atrial fibrillation (AF) risk prediction algorithm and diagnostic test for the identification of patients with atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

Practice inclusion criteria for the trial are as follows;

* GP Practices within National Institute for Healthcare Research (NIHR) Clinical Research Network: West Midlands (CRN: WM) CRN: WM
* GP Practices using EMIS as their electronic medical record system of choice. Patient inclusion criteria for the trial are as follows;
* Patients registered at a participating practice, aged ≥30 years and without an AF diagnosis.
* Patients with a valid index date (see Section 3.3) Participant inclusion criteria for participation in the intervention arm are;
* As above, and who have provided written consent to: attend a research clinic, AF diagnosis check using a 12-lead ECG, and for access to medical records Participant inclusion criteria for participation in further AF remote diagnosis with an AliveCor Heart Monitor are;
* As above, and those with a negative or indeterminant ECG
* As above, and those with access to a smartphone

Exclusion criteria:

* Patients \<30 years
* Patients with an existing diagnosis of AF
* Patients for whom the healthcare professional feels the study is unsuitable
The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer

The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:

1. Patients with advanced breast cancer need family companionship
2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients who are pathologically or cytologically diagnosed as cancer
* TNM clinical stage IV

Exclusion Criteria:

* Terminal cancer patients who are mentally ill or confused and refuse to participate in the survey
Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System

Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. A modified Delphi review reported water exchange showed the highest overall ADR, ADR in screening cases, and in the right side of the colon compared with water immersion and air (or CO2) insufflation. One of the plausible mechanisms of improving ADR by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. However, no RCT has been performed to evaluate the effect of CADe on WE colonoscopy.

Therefore, investigators will conduct a RCT comparing the ADR of CADe assisted colonoscopy inserted with either WE or insufflation. Our hypothesis will be that CADe assisted WE colonoscopy achieves higher ADR than CADe assisted air insufflation colonoscopy.

The primary end point will be ADR, defined as the proportion of patients with at least one adenoma. Serrated lesions will not be counted as part of ADR. Secondary outcomes were FP rate, adenomas per colonoscopy (APC), polyp detection rate, polyps per colonoscopy, SL detection rate, cecal intubation rate, withdrawal time. Missed polyp will be defined as a polyp recognized by endoscopist, but is not detected by CADe system at an interval of 2 seconds. The detected polyps will be classified in sizes, morphology (polypoid or nonpolypoid). Investigators also record the detection of every polyp by the endoscopist or the CADe system in time priority. If a polyp is detected by performing endoscopist at the same time as the CADe system, the credit will go to the endoscopist. The colonoscopy procedure will be recorded as CADe over-laid videos and be reviewed for FP characteristics, numbers and appearance time afterward. The withdrawal time will be divided into inspection time, cleaning time and polypectomy time. Boston Bowel Preparation Scale score and the amount of water infused and aspirated will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients, undergoing screen, diagnostic or surveillance colonoscopy performed by the participating endoscopists will be enrolled.

Exclusion Criteria:

* We excluded patients age \< 50 or \> 80 years old, undergone colonoscopy in the past 3 years, partial intake of bowel preparation, renal failure, previous colonic resection, scheduled for polypectomy, American Society of Anesthesiology (ASA) Risk Class 3 or higher, and lack of written informed consent.
The Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Breast Cancer

Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment for breast cancer.

The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane (125mg/m2) Combined With Q3week Epirubicin (100mg/m2) in early operable (stage of T2-4N0-3M0) breast cancer. This study will be an open label non randomized, single arm, single center study.

The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is feasible and achieves high response rates.

It is proposed that 50 patients will be enrolled in this study. The target population is women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic therapy.

The primary objective of the trial is to determine the overall response rate. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Women and men at least 18 years of age or older.
3. Pathological confirmation of breast cancer
4. Tumor stage(TNM): T2-4N0-3M0
5. No evidence of distant metastasis
6. Adequate bone marrow, hepatic, and renal function
7. Measurable disease as per RECIST criteria
8. Karnofsky≥70
9. Laboratory criteria:

PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN

Exclusion Criteria:

1. Presence of metastatic disease.
2. Inflammatory breast cancer.
3. Bilateral breast cancer.
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
5. other malignant tumors (concurrent or previous).
6. Pregnant woman.
7. Hypersensitive to any drug in Abraxane or Epirubicin regimen or any ingredient of Abraxane or Epirubicin.
8. Any severe systemic disease contraindicating chemotherapy.