cyrilzakka/clinical-trials huggingface dataset:
A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

The primary objective of the study is to show that in Chinese adults with CABP, a course of IV/PO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, IV/PO moxifloxacin. The study is designed as a bridging study, to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese.


Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent obtained before any protocol specific assessment is performed.
2. Male or female, ages 18 years or older.
3. Has at least 3 of the following symptoms:

   * Cough
   * Production of purulent sputum
   * Dyspnea (shortness of breath)
   * Chest pain
4. Has at least 2 of the following abnormal vital signs:

   * Fever or hypothermia documented by the investigator (temperature \> 38.0°C or \< 36.0°C)
   * Hypotension with systolic blood pressure (SBP) \< 90 mmHg
   * Heart rate (HR) \> 90 beats per minute (bpm)
   * Respiratory rate (RR) \> 20 breaths/minute

Exclusion Criteria:

1. Has received antibacterial treatment \>24hr within the 72hr window prior to randomization.

   Subjects may be eligible despite prior antibacterial therapy if they had been treated with short action time antimicrobial for ≤24h, or if they have received \> 48 hours of prior systemic antibacterial therapy for the current episode of CABP with unequivocal clinical evidence of treatment failure.
2. Is known or suspected to have CABP caused by a pathogen that may be resistant to either test article (eg, Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystis jiroveci, obligate anaerobes, mycobacteria, fungal pathogens).
3. Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess.

   -
TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation

Urethral stenosis has a recurrent character. The clean intermittent self-catheterization can be proposed for repeat stenosis. This study seeks to explore the tolerance of clean intermittent self-catheterization in the evolution of urethral stenosis after urethrotomy.


Eligibility Criteria:
Inclusion criteria:

* Men between 18 and 80
* First or second uretral stenosis, diagnosed with uretral fibroscopy

Exclusion criteria:

* Not multiple, strength or long stenosis
* No previous surgery of the urethra
* Refusal to participate to the study
* Inability to perform self-catheterization
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging

To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.

This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days
2. Subject is willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
3. Subject's ventricular bipolar capture threshold is stable \< 2.5V @ 0.5ms
4. Subject's ventricular sensing is measurable (patient has underlying rhythm \> 30bpm) and the sensing amplitude is stable \> 4mV
5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
6. Subject is willing and able to comply with the prescribed follow-up tests and procedures
7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form)

Exclusion Criteria:

1. Subject is pacemaker dependent
2. Subject has a non SJM MRI compatible endocardial lead implanted or capped
3. Subject has another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
4. Subject has a high voltage lead revision incidence \< 60 days of the enrollment visit
5. Subject has other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol NOTE: Non-removable dental implants may be included
6. Subject has a lead extender, adaptor, or capped/abandoned lead
7. Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.
8. Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study
9. Subject has a life expectancy of less than 12 months due to any condition
10. Subject has exclusion criteria required by local law (e.g., age)
Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent or assent form
* Male/female, 9 to 45 years of age, inclusive
* Body weight between 33 and 136 kg, inclusive
* Facial acne vulgaris with:
* 20-50 inflammatory lesions (papules, pustules and nodules)
* 30-100 noninflammatory lesions (open and closed comedones)
* No more than 2 nodules
* Investigator's Global Assessment (IGA) score of moderate (3) or severe (4)
* Negative urine pregnancy test at baseline - females of childbearing potential
* Agrees to use an effective method of contraception throughout the study
* Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
* Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI).

Exclusion Criteria:

* Has a dermatological condition of the face that could interfere with the clinical evaluations
* Has a history of any of the following:
* Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
* Pseudomembranous colitis or antibiotic-associated colitis
* Treated for any type of cancer within the last 6 months
* Has known resistance to other tetracyclines
* Has receive any of the following treatments within 12 weeks of screening:
* Systemic retinoids
* Systemic corticosteroids
* Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
* Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
* Has used any acne affecting treatment without an appropriate washout period
* Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
* Is pregnant, lactating or planning a pregnancy during the study period
* Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia
* Has drug-induced acne
* Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
* Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study
* Has previously participated in any clinical trial involving the use of sarecycline
* Is judged by the Investigator to be unsuitable for any reason.
AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): 18 to 27 kg/m 2
* Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
* Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.

Exclusion Criteria:

* Clinically relevant disease and/or abnormalities (past or present)
* Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
* Use of any prescription medication within 14 days of Day 1
* Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
* Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM

In this prospective, multi-center, randomized, open-label, parallel group trial, the safety and efficacy of needle-free injector will be compared with insulin pen after 2 weeks of treatment in patients with type 2 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in Time in Range (TIR), a newly recommended measurement of blood glucose fluctuations.

The objective of the current study is to investigate the efficacy, safety and tolerability of needle-free injector compared to conventional insulin pen given for 2 weeks as the insulin carrier in patients with type 2 diabetes mellitus. The primary endpoint in this study is the change from baseline in TIR (after 2 weeks of treatment) in all patients with baseline and at least one post baseline measurement. Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 200 patients will be enrolled in the study. Patients who qualify will be randomized to needle-free injector group or conventional insulin pen group. Duration of treatment includes 1-week screening period, 2-week treatment observation period and 2-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 and ≤75 years with type 2 diabetes;
* HbA1c ≥ 7.5 to ≤11.0%;
* Receipt of premixed insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study, and insulin dose adjustments ≤ 10% within 4 weeks before enrollment (dose adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);
* BMI ≤ 32kg / m2.

Exclusion Criteria:

* Patients with any of the following conditions will be excluded:
* Pregnant or lactating women
* Severe hypoglycemia within one month; diabetic ketoacidosis or hyperosmotic diabetic status within 6 months prior to informed consent
* Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
* Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent
* Severe mental instability, or alcohol abuse, or drug abuse
* Skin lesions at the insulin injection site
* Cancer within 5 years prior to informed consent
* Pancreatitis of severe infectious diseases within 1 months prior to informed consent
* Known hypersensitivity or allergy to the insulin
* Renal impairment (CKD-EPI eGFR\<60ml/min)
* Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined
* Participation in another trial within 2 months prior to informed consent
* Patients that investigators believe may fail to complete the study
Microlyte in Prevention of SSI After Open Ventral Hernia Repair

Participants who are scheduled to have open ventral hernia repair (OVHR) will be asked to take part in this study.

The purpose of this study is to find out if placing Microlyte (which is a dissolvable sheet coated in silver) on the surgical incision is better than placing nothing on the surgical incision when it comes to decreasing the chance of surgical site infections.

The study device has been cleared by the Food and Drug Administration (FDA) for use on surgical incisions.

A total of 280 participants will be included in the study.

Participation will last for about 90 days.

The aim of our study is to assess the impact of Microlyte-AG® (Imbed Biosciences, Fitchburg, WI), a silver-coated bioabsorbable matrix, on surgical site infection (SSI) on patients undergoing clean open ventral hernia repair (OVHR) at Carolinas Medical Center/Atrium Health (Charlotte, NC), Prisma Health-Upstate (Greenville, SC), and Mission Health/HCA Healthcare (Asheville, NC).

Those who agree to participate in the study will undergo the following:

Information will be collected, including demographics, past medical and surgical history, and hospital outcomes.

On the day of surgery, participants will be "randomized" into one of the study groups listed below.

* Group 1: The study device will be cut into strips and placed in the surgical incision
* Group 2: Nothing will be placed in the surgical incision

For both groups, the surgical incision will then be closed with absorbable sutures, which is the usual treatment.

Participants will be seen by the study doctor 30 and 90 days after surgery for a checkup. At the 30-day visit, participants will have a physical examination, and the study doctor will check to see if any complications have happened since the last visit. The 90-day follow-up visit can be done in person or over the telephone and will be done to check and see if there have been any problems with the healing of the surgical incision.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years of age
* Patients undergoing open hernia repair with retromuscular or preperitoneal placement of polypropylene mesh in clean (Class I) operative fields, and who are candidates for complete skin closure
* Capable and willing to attend the scheduled postoperative visits
* Signed ICF for study enrollment

Exclusion Criteria:

* Prisoners
* Minimally invasive repairs (laparoscopy, robotics)
* CDC Wound Class II-IV
* Irrigation of the wound or peritoneal cavity with antibiotic or antimicrobial fluid
* Inability to completely close the midline fascia
* Mesh placed as a bridge, onlay, or intraperitoneal position to the fascia
* Skin left open or packed at the time of the index operation
* Use of wound wicks at the time of the index operation
* Use of an investigational product within the preceding 60 days
* Allergy to silver
Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients

The primary objective of this study is to measure efficacy of our new protocol by monitoring the results of our routine respiratory cultures at the end of the new standard treatment, and during routine visits for 1 year from initiation of therapy for Staphylococcus aureus. The secondary objective will include determining the clinical course (pulmonary exacerbations, antibiotic use, hospitalizations, pulmonary function tests) of patients who underwent the protocol.


Eligibility Criteria:
Inclusion Criteria:

Eligible participants will include all patients with CF who test positive for SA from respiratory tract culture (throat, nares or expectorated sputum) and are 2-23 months of age at protocol presentation.

Exclusion Criteria:

Patients co-infected with other bacteria (e.g. Pseudomonas) or documented to have an allergy or resistance to any of the intervention substances will be excluded.
Artificial Intelligence for Sepsis Prediction in ICU

The development of sepsis prediction model in line with Chinese population, and extended to clinical, assist clinicians for early identification, early intervention, has a good application prospect. This study is a prospective observational study, mainly to evaluate the accuracy of the previously established sepsis prediction model. The occurrence of sepsis was determined by doctors' daily clinical judgment, and the results of the sepsis prediction model were matched and corrected to improve the clinical accuracy and applicability of the sepsis prediction model.

The sepsis prediction model adopted in this study has been completed in the preliminary preparation, which was constructed on 7,000 patients since the establishment of comprehensive ICU, and the sepsis 3.0 diagnostic standard was adopted.The sepsis prediction model was built using Python platform and XGBoost algorithm, which was used to predict the incidence of sepsis in ICU patients within 24 hours. The overall accuracy was 82%, and the area under the Auroc curve was 0.854.

Patients who met the inclusion and exclusion criteria were given a daily prediction of sepsis model, and a quantitative checklist was formed based on the test results.There are two kinds of forecast outcomes: low risk and high risk.Quantitative checklists are available to attending physicians to improve diagnostic efficiency.The results were kept confidential to the clinician.

All patients were diagnosed with sepsis by two senior attending physicians at a fixed time. The diagnosis consisted of two types: yes and no.If two attending physicians have different opinions, the third attending physician will be included for correction diagnosis, and the presence of sepsis will be determined in a 2:1 manner.The attending physicians are independent of each other.

When the diagnosis results of the attending physician are input into the system, the prediction results of yesterday's sepsis prediction model are compared and calculated to determine the accuracy of the prediction model

Eligibility Criteria:
Inclusion Criteria:

All patients with acute critical illness who are eligible for admission to ICU during the study period

Exclusion Criteria:

1. Patients under the age of 16;
2. Pregnant and parturient women;
3. Patients who planned to be admitted to the department for surgery and transferred the next day after evaluation;
4. Patients admitted to the department and diagnosed with sepsis;
5. Patients with ICU stay less than 24 hours;
Photobiomodulation on the Salivary Glands of Patients With Xerostomia Induced by the Use of Benzodiazepines

Depression is the most common mental illness and antidepressants are in the first line of treatment of depressed patients. This therapeutic class is inevitably associated with side effects and adverse reactions, xerostomia being a symptom that seems to be transverse to them all. Saliva performs multiple functions and plays a vital role in protecting the health of the soft and hard tissues of the oral cavity. Reductions in salivary flow are most often manifested as dry mouth, and this is the subjective complaint called xerostomia. Although xerostomia is the most frequent indication of reduced salivary production, it is not invariably associated with hyposalivation. The user of antidepressant drugs has a number of important systemic and oral complications. Treatment for salivary changes remains unknown, but low-level laser therapy has been shown to be effective in improving salivary flow in patients with xerostomia due to diabetes, Sjogren's syndrome, chemotherapy and radiotherapy for head, neck and lung cancer. This randomized controlled trial aims to evaluate oral symptoms related to salivary gland function and mucosal condition of depressed patients, as well as the effects of photobiomodulation on salivary flow. Sixty patients will be included in the protocol, after signing the Informed Consent Form. They will undergo anamnesis, physical evaluation and oral health self-perception questionnaires and symptoms related to salivary gland function and then will be divided into two groups: Photobiomodulation (PBM) (n=30); will have their larger salivary glands irradiated with Diode laser (808nm, 4J per point, 40s) and placebo (PCB) (n=30), which will be subjected to a simulation, where the application protocol will be repeated, but with the laser off. Previous and post treatment sialometries will be performed to compare saliva volume. Biochemical analysis, in which total protein and calcium will be measured, will also be performed.


Eligibility Criteria:
Inclusion Criteria:

* Participants in good general health, but who have depression with regular use of benzodiazepines;
* Complaints of xerostomia or hyposalivation;
* Over 18 years of age;
* Be able to understand and sign the Informed Consent Form.

Exclusion Criteria:

* Participants who present current acute systemic infectious conditions;
* Chronic kidney disease;
* Diabetics;
* Participants with a history of mental disorders other than depression and anxiety;
* Participants without conditions for dental treatment in the month of referral to the dental service;
* Hemodynamic instability;
* Signs and symptoms related to the cardiovascular systems;
* Acute systemic infectious processes;
* Acute cardiovascular disease;
* Those with any type of photosensitivity;
* Neoplasms in the region of glands;
* Under 18 years of age;
* Pregnant or lactating women;
* Participants with xerostomia not induced by anxiolytics.