cyrilzakka/clinical-trials huggingface dataset:
Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response

We are using a tool called QtNGS (quantitative targeted amplicon-based next-generation sequencing ) to measure the abundance of local pathogens in patients with ventilator-associated lower respiratory tract infections. We hypothesize that changes in pathogen abundance before and after treatment are related to patient outcomes. This study aims to evaluate the effectiveness of the tool by analyzing the changes in pathogen abundance and exploring the relationship between these changes and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and above.
* Previously relied on mechanical ventilation (endotracheal intubation or tracheotomy) for breathing assistance, and the duration of mechanical ventilation was more than 48h.
* Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 12\*10\^9/L or less than 4\*10\^9/L), and the presence of purulent tracheal secretions.

Exclusion Criteria:

* Bronchoscopy and respiratory specimen collection were not performed at screening (Day 1) and after 3 days of treatment (Day 4).
* Refusal of patients or families to participate in the study
* After initial screening, bronchoscopy was performed to obtain BALF for bacterial culture. The results of the culture showed no evidence of infection by study-associated lower respiratory pathogens.

Note: The evidence of infection was defined as a single positive bacterial culture (pathogen quantification ≥10\^4 cfu/ml or "++" and more) on Day1. And the study-associated causative pathogens are Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, and Staphylococcus aureus. Additionally, the included patient must have single infection with one of these pathogens.
Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen

The purpose of this study is to provide an initial assessment of the gastrointestinal safety of a 7-day regimen of PLA-695 compared to placebo or naproxen.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women of nonchildbearing potential, aged 18 to 60 years.

Exclusion Criteria:

* Abnormal baseline endoscopy.
* Positive Helicobacter pylori serology.
Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery

Neonates, children with single ventricle congenital heart disease, and those undergoing multiple complex cardiac surgeries are at high risk of increased perioperative blood loss, and blood product transfusions. In addition, some of these patients will present an increased risk of postoperative thromboembolic complications. For a long time, bleeding management has been based on the empiric administration of different blood products (e.g. platelet concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic agents, and surgical manipulation. Recently, the use of viscoelastic tests (e.g. thromboelastography (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better assessment of perioperative coagulopathy, and a more 'rational' treatment of bleeding. While TEG and ROTEM record the viscoelastic properties of whole blood by measuring mechanical impedance and related changes during clot formation, T2MR, a miniaturized, magnetic resonance-based diagnostic platform, measures how water molecules react in the presence of magnetic fields to evaluate a broad range of hemostasis measurements. In this study, we will prospectively collect demographic data, surgical characteristics, the amount of perioperative bleeding and blood product transfusion, results of laboratory assays, and postoperative outcomes (30-day follow-up or until discharge), with the aim to assess our current practice, and develop an algorithm-based approach for the administration of targeted blood product and pro-coagulant therapies. Our goals are: the reduction of blood product utilization, the reduction of the incidence of massive bleeding and postoperative thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Neonates and infant patients (0 -12 months of age) undergoing complex cardiac surgical procedures
* cardiac surgery patient \> 12 months of age who has previously undergone 2 or more sternotomies

Exclusion Criteria:

* child in a moribund condition (American Society of Anesthesiology (ASA 5)
* children with a hematological and/or oncological disease
* Jehovah witnesses
* If the child is only undergoing a patent ductus arteriosus (PDA) ligation or other procedures not considered at risk for thrombosis and/or bleeding or they do not provide consent for enrollment (e.g. Ventricular Septal Defect repair)
Effects of Moderate Exercise And Interval Exercise On Sleep Quality

This study aimed to explore the effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.

Medical staff with sleep disturbances due to their night-shift work were randomized to either a treadmill walking session for 47 minutes with moderate intensity (the heart rate reaches 70\~75% of the maximum heart rate), treadmill running section for 28 minutes with intermittent high-intensity (the heart rate reaches 90\~95% of the maximum heart rate for 4 minutes and 50\~70% for 3 minutes), or a quiet-rest control, 14 hours before undertaking a continuous night shift. Sleep quality was assessed by ActiGraph with subjective questionnaire for 1 night and 3 nights after exercise. Tests were performed (t-tests or χ2 tests) to test for differences between any two of the three intervention trials.

Eligibility Criteria:
Inclusion Criteria:

* medical staff who have worked at least three consecutive night shifts
* reporting sleep disturbed during the night shift
* not taking sleep/psychotropic medications
* no clinical diagnosis of sleep apnea or other sleep disorder
* not exercising regularly

Exclusion Criteria:

* not medical staff
* without night shift
* taking sleep/psychotropic medications
* exercising regularly
Radiographic Changes and Clinical Implications of Implantation of Shortened Uncemented Femoral Stems in THA

The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed.

Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.

The objective of this study is to observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively.

Eligibility Criteria:
Inclusion criteria:

* Male or female (age ≥18 years old)
* Subject operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head
* Subject who received a THA between January 2015 and December 2019
* Subject who received an uncemented shortened SCC or SCLA femoral stem
* Radiological data available: pre-operative, immediate post-operative and post-operative at a minimum of 2 years (≥24 months)
* Subject not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Subject having expressed its opposition to the reuse of its data for scientific research purposes.
* Patient operated for inflammatory pathology or major dysplasia, recovery
* Associated fractures or sequelae of fractures
* Patient having presented intraoperative or early complications such as infections, intraoperative fracture, dislocation of the hip following the installation of the THA
* Revision of hip arthroplasty during the study follow-up period for a cause not studied in the study.
Tranexamic Acid Dosing in Adult Spinal Deformity Surgery

The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.

After consent is obtained and the patient is enrolled in the trial, patients will be assigned de-identified, unique identification (ID) numbers. Randomization of these IDs to either low or high dose TXA will occur via a computer generated random assignment. Given the variations that may exist in surgical technique (e.g. performance of osteotomies), stratified randomization will be performed by attending surgeon. Based upon the randomization, the pharmacy will prepare TXA for one of two intravenous dosing protocols:

1. Low Dose (Standard of Care/Control): Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion
2. High Dose (Study Group): Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion.

The surgeon, anesthesia team, and operating room staff will be blind to the concentration of TXA in the medications received. Treatments may be "unblinded" at the discretion of the surgeon and anesthesiologist, in cases of extreme blood loss. If additional anti-fibrinolytics are given, the change in dose will be recorded.

Post-operative care will be the same as any other patient and data collection will be information contained in the patient's medical record that is part of routine, standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (PSF) for adult scoliosis

Exclusion Criteria:

* Patients with acquired defective color vision
* Subarachnoid hemorrhage
* Active intravascular clotting
* Hypersensitivity to tranexamic acid or any of the ingredients
* Patients who pre-donate autologous blood for intra- or post-operative use (Directed donor units are acceptable)
* History of suspected blood disorders or abnormal coagulation laboratory results
* Current anticoagulation therapy that cannot be interrupted
* History of deep vein thrombosis (DVT)
* Impaired renal function or creatinine clearance \<60 ml/min
* Pregnancy or women who are lactating/breastfeeding
* Women on hormonal contraceptives
Assessment of Interactions Between Methamphetamine and Aripiprazole - 1

The purpose of this study is to assess the interactions between intravenous methamphetamine and aripiprazole.

This is a double-blind, placebo-controlled human laboratory clinical pharmacology study to assess potential interactions between intravenous d-methamphetamine infusion and treatment with oral aripiprazole.

Eligibility Criteria:
Inclusion Criteria:

* Must meet DSM-4 criteria for methamphetamine abuse or dependence and are non-treatment seeking.
* Ability to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.

Exclusion Criteria:

* Please contact the site for more information.
Point of Care Susceptibility Testing in Primary Care

The purpose of this study is to determine whether point-of-care susceptibility testing improve correct choice of antibiotics, clinical and microbiological outcome in patients with uncomplicated urinary tract infection in general practice compared to point-of-care urine culture.

700-900 patients with symptoms of uncomplicated urinary tract infection, consecutively contacting their GP, randomized to either point of care test (POCT) urine culture and empirical treatment or POCT urine culture and susceptibility testing and targeted treatment. Patients are included until 440 with verified positive cultures are included. The two groups are compared with regard to correct choice of antibiotics, clinical remission and microbiological cure rates.

Eligibility Criteria:
Inclusion Criteria:

* Female adult patients
* 18 years or older
* Presenting at their GP with dysuria
* Frequency or urgency, which have been present for 7 days or less and where the GP suspects uncomplicated UTI.
* Patients should be able to deliver a mid-stream urine sample, to provide informed consent and be willing and able to fill out a symptom diary.

Exclusion Criteria:

* Negative dipstick analysis
* Complicated urinary tract infection
* Known pregnancy
* Severe systemic symptoms, high fever, flank pain
* Recent bladder surgery (within past 4 weeks)
* Urinary tract abnormalities
* Serious systemic disease
* Life-threatening cancer
* Insulin dependent diabetes
* Long-term corticosteroid treatment
* Other conditions with compromised immunity
* Former participation in the study
* Patients presenting on a Friday (since the POCT must be read after 24 hours)
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)

The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral ocular surgery in the day prior to study enrollment.
* Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).
* Aged 2 years or older on the day of consent.
* Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion.
* Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.

Presurgical Exclusion Criteria:

* Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment.
* Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug.
* Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis.
* Any history of glaucoma or ocular hypertension in the study eye.
* History or presence of endogenous uveitis.
* Any current corneal abrasion or ulceration.
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
* Allergy to similar drugs, such as other corticosteroids.
* History of steroid-related IOP increase.
* Scheduled surgery on the contralateral eye during the treatment period.
* Unwilling to discontinue use of contact lenses during the study period.
* Pregnancy or lactation.
* Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
* Prior participation in the study described in this protocol.
* Unable or unwilling to give signed informed consent prior to participation in any study related procedures.

Postsurgical Exclusion Criteria:

* Ocular hemorrhage which interferes with evaluation of postsurgery inflammation.
* Injection of gas into the vitreous body during surgery.
* Presence of IOP ≥24 mm Hg on Day 1 after surgery.
Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis

To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.


Eligibility Criteria:
Inclusion Criteria:

1. Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
2. Children aged from 1 to 3 years (girls and boys)
3. Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
4. No allergic sensitization
5. Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes

Exclusion Criteria:

1. Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
2. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
3. Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
4. Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
5. Any regular therapy except Vitamin D or Fluoride
6. Chronic illnesses of different aetiology
7. Premature birth or diagnosis of bronchopulmonary dysplasia
8. Gastro-oesophageal reflux
9. Hereditary fructose intolerance
Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
* Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of \>20%.
* Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically \> 2.5mm)confirmed by pre op MRI and/or CT.
* Central canal cross sectional area clearly reduced per MRI/CT report.
* If present, anterior listhesis ≤ 5.0mm (preferred) and stable.
* Able to walk at least 10 feet unaided before being limited by pain.
* Available to complete 26 weeks of follow-up.
* A signed Informed consent Form is obtained from the subject.
* Adults at least 18 years of age.

Exclusion Criteria:

* Prior surgery at intended treatment level.
* History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
* Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
* Disk protrusion or osteophyte formation severe enough to confound study outcome.
* Facet hypertrophy severe enough to confound study outcome.
* Bleeding disorders and/or current use of anti-coagulants.
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory (NSAID) within five days of treatment.
* Epidural steroid administration within prior 3 weeks(of procedure or sham)
* Inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
* Metabolic wound healing pathologies deemed by Investigator to compromise study outcome.
* Dementia and/or inability to give informed consent.
* Pregnancy and/or breastfeeding.
* On Workman's Compensation or considering litigation associated with back pain.
A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus (Type 1 or 2)
* Decreased vision due to diabetic macular edema in at least 1 eye
* Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion Criteria:

* Stroke or heart attack within the past 3 months
* History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
* Cataract or refractive surgery in the study eye within the last 3 months
* Laser photocoagulation of the study eye within the last 3 months
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults

This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.

Adults (\>20 years) with newly diagnosed (\<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of type 1 diabetes within last 6 months
* Age 20-45 years
* fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
* BMI between 17 and 30 at screening

Exclusion Criteria:

* Significant disease or condition other than type 1 diabetes
* Diabetes-related complications
* Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
Safety and Patient Satisfaction With GLASH VISTA™ (Bimatoprost 0.03%) in the Treatment of Eyelash Hypotrichosis in Japan

This is a post-marketing surveillance study in Japan that will evaluate the safety and patient satisfaction with GLASH VISTA™ (bimatoprost cutaneous solution 0.03%) in the treatment of hypotrichosis of the eyelashes.


Eligibility Criteria:
Inclusion Criteria:

-Patients who have been prescribed GLASH VISTA™ in clinical settings and filled at least one prescription for GLASH VISTA™.

Exclusion Criteria:

-None.
Observational Study About In-patients Admitted With Fever

Fever is a common symptom in patients with infectious diseases. This study hopes to understand the epidemiological characteristics of patients hospitalized due to fever through observational research, including: clinical characteristics, etiology of fever and prognosis after treatment. So as to further search for biochemical or other serological indicators to predict the diagnosis and prognosis of infectious fever and non-infectious fever, and try to establish relevant prediction models.

This study mainly prospectively analyze the clinical data of patients with fever with/without other symptoms admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the epidemiological characteristics, diagnosis and prognosis of these patients. This is an observational study. All subjects will receive the currently recognized routine test of fever according to their disease and corresponding etiological treatment if needed. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to white blood cells, C-reactive protein, Procalcitonin, ferritin, blood culture, therapeutic drugs, etc. Etiology and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. All subjects will sign informed consent.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to department of infectious diseases because of fever

Exclusion Criteria:

* patents who refuse to sign informed consent