cyrilzakka/clinical-trials huggingface dataset:
Cross Transmissions of Pseudomonas Aeruginosa Between Children From a Same Cystic Fibrosis Center.

Cystic fibrosis is the most common hereditary autosomal recessive disease in the Caucasian population. The diseases is caused by a mutation of the gene coding for the CFTR protein (Cystic fibrosis transmembrane conductance regulator), an ion channel present at the apical pole of the epithelial cells. The channel dysfunction induces a deficit in hydration and a hyperviscosity of different exocrine secretions.

Clinically, Cystic fibrosis is a multi-systemic disease. Pulmonary and pancreatic involvement are classically in the foreground. Degradation of respiratory function, associated with acute and chronic infections, represents the major cause of morbidity and mortality.

Pseudomonas aeruginosa is a ubiquitous gram-negative bacillus found primarily in stagnant water. Pseudomonas aeruginosa is capable of colonizing the digestive, pulmonary and urinary mucosa and the skin. This bacterium is incriminated in many opportunistic infections including respiratory infections in patients with cystic fibrosis. Pseudomonas aeruginosa infection is the most common parenchymal lung infection in the Cystic fibrosis community.

Pseudomonas aeruginosa chronic carriage represents a factor of poor prognosis associated with an increase in morbidity and mortality. Complications related to chronic carriage of Pseudomonas aeruginosa justify the implementation of strategies of eviction, screening and eradication of acute Pseudomonas aeruginosa infection.

In addition to Pseudomonas aeruginosa contamination of patients via the environment, hand and airborne infections between patients with Cystic fibrosis have been reported. Measures to eliminate cross-transmissions have therefore been implemented in a majority of hospitals.

The aim of the study is firstly to identify the number of Pseudomonas aeruginosa cross-transmissions between patients with Cystic fibrosis followed-up in Cystic fibrosis center of HUDERF. Investigator will use the Pulsed-Field Gel Electrophoresis to assess the possibility of cross-infection.

Depending on the results, Investigator will implement new strategies to avoid future cross-contamination in our different places of care (consultation, hospitalization, physiotherapy...).


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patients aged 0-20y followed in Cystic fibrosis at HUDERF
* For each participant, both parents or legally acceptable representative(s) must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study.
* Assent is also required of children capable of understanding the study (typically participants 7 years of age and older).

Exclusion Criteria:

* None
Optical Coherence Tomography (OCT) Data Collection Study

Collect OCT data to evaluate the range and age trend of ocular measurements.

This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.

Eligibility Criteria:
Inclusion Criteria:

* Subject is not an employee of the eye clinic.
* Age ≥18 to 90.
* Able and willing to undergo the test procedures, give consent, and to follow instructions.
* Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
* Caucasian decent (self-reported).
* Negative history of glaucoma.
* Intraocular pressure ≤21mmHg.
* Best corrected visual acuity ≥0.5.
* Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
* Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
* Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
* When both eyes are eligible, both eyes enter the study for inter-eye asymmetry; one randomly selected eye will be used for all other measures.

Exclusion Criteria:

* Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
* Unusable disc stereo photos.
* Inability to undergo the tests.
* Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:

  * Retina completely included in image frame,
  * Quality Score ≥ 20 in the stored ART mean images, and
  * For ONH-R scan: Center position error ≤ 100 μm.
* Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
Encouraging Judicious Prescribing of Opioids in Los Angeles County

In collaboration with the Los Angeles County Medical Examiner's Office and the State of California's controlled Substance Utilization Review and Evaluation System (CURES), the investigators propose to review opioid poisonings over 12 months and send letters to prescribers in California when at least one of the provider's prescription(s) was filled by a patient who died of an opioid poisoning in Los Angeles County. The letters will be non-judgmental and factual, explaining that a patient of the provider who was being treated with prescription narcotics died of an opioid poisoning. The letters will also encourage judicious prescribing including use of the CURES system before prescribing. The investigators will evaluate physician prescribing practices over 24 months (12 months pre- and 12 months post-letter) using data from the CURES database. The investigators' hypothesis is that letters will make the risk of opioids more cognitively available and that physicians will respond by prescribing opioids more carefully, resulting in fewer deaths due to misuse and more frequent use of the CURES system.


Eligibility Criteria:
The investigators will not be enrolling subjects. This is an evaluation of a public health intervention involving sending prescriber's factual and nonjudgmental letters, signed by the County Medical Examiner, that would state that a patient the provider had treated with controlled substances died of an opioid poisoning.

Inclusion Criteria:

* Prescribers in California for whom at least one of their prescription(s) was filled by a patient who died of an opioid poisoning in Los Angeles County

Exclusion Criteria:

* Prescriber is licensed outside the State of California and does not hold a California license, but the prescription was filled in California
* The prescriber does not have a CURES report on record
* The prescriber has issued only one opioid prescription in the last 12 months since the time of the deceased death (and the prescription was to the deceased)
* Prescriptions with unknown Drug Enforcement Agency (DEA) number
Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine

This is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered Bacillus subtilis spore extract which contain Spike protein of the SARS-COV2 on the spore coat.

COVID-19 immunization reduces the risk of COVID-19 and potentially serious complications. In clinical trials, all COVID-19 vaccines currently authorized for use in the United States are beneficial in protecting adults and children 5 years and older against COVID-19, including severe illness. So far, studies looking at how COVID-19 vaccines work in real-world conditions (vaccine effectiveness studies) have shown that they work well. However, it has been reported that most of the antibodies in people who received the second dose of COVID-19 vaccine had been dramatically decreased.

Bacillus subtilis (B. subtilis) is a generally regarded as safe organism and it is a common food source. The investigators have used an engineered Bacillus subtilis spore which express and display the spike protein receptor binding domain (sRBD) of the SARS-CoV-2 on the surface. The investigators have proved that it successfully increased the neutralizing antibody against sRBD in unvaccinated mice and human individuals after oral administration.

On this basis, the investigators designed and developed an oral antibody booster by extracting the spore surface of B. subtilis. This supplement has the advantage of being stable and effective, free of recombinant plasmid, and can be served as a potential antibody booster to existing vaccines.

Mice toxicity and efficacy test was conducted and the experiment proved that the B. subtilis spores extract was effective in inducing immune response, and it was safe and did not cause any significant adverse effect.

The B. subtilis spore extract will be further studied in a human trials through oral administration to test its safety and the immune effect resulted in human body.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age over 12 years
* the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
* participant vaccinated with COVID-19 over 6 months
* anti-SARS CoV 2 neutralizing antibody is negative in serum.

Exclusion Criteria:

* pregnant women
* history of COVID-19 infection or showing COVID-19 infection symptoms
* having had contact to people with known COVID-19 infection in the last 14 days
* having fever (\> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
* positive real time RT-PCR COVID-19 test.
* persons with autoimmune diseases
* allergic diathesis or any clinically significant allergic disease (i.e. asthma)
* any condition that might impair the immune response
* recent or current immunosuppressive medication
* any other vaccine application 5 months before the first dose
Lutropin Alfa in Women at Risk of Poor Response

Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Participants who were at risk of poor response by at least one of the following criteria: a) \<3 follicles in last cycle, or less than or equal to (\</=) 2 metaphase II oocytes, or estradiol (E2) \<600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicle-Stimulating Hormone (FSH) \>8.5 milli IU/L
* Participants with normal baseline luteinizing hormone and E2 levels
* Regular menstrual cycles of 25-35 days
* Presence of both ovaries and uterus able to withstand pregnancy

Exclusion Criteria:

* Participants who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity
* Participants with more than 3 previous assisted reproductive techniques (ART) cycles
* Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding
* Participants who had any contraindication to being pregnant
* Active substance abuse
* Participants who had simultaneously participated in another clinical drug trial
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes

This study aims to compare the maternal, fetal, and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes.

The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy.

Primary Outcome: treatment failure is defined as the initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects.

Secondary Outcomes:

Maternal:

* Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment
* Incidence of maternal hypoglycemia
* Reported maternal side effects
* Maternal weight gain
* Preterm delivery
* Development of pregnancy-induced hypertension
* Labor dystocia.
* Instrumental delivery and its indication (fetal compromise, delay in progress, or maternal exhaustion)
* Mode of delivery
* Incidence of third and fourth perineal tear

Fetal and neonatal:

* Fetal large for gestational age
* Intrauterine fetal death
* Newborn weight
* Gestational age at delivery
* Neonatal birth injuries
* Stillbirth and neonatal death
* Apgar score at 1 minute

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over 18 years old.
* Gestational age between 24 - 28 weeks.
* New diagnosis of gestational diabetes mellitus using a 2-hour glucose tolerance test.
* Medical therapy is indicated to control blood glucose following the failure of diet and lifestyle changes to solely achieve glycemic control (A2GDM).

Exclusion Criteria:

Patients with pre-gestational diabetes.

* First trimester fasting blood glucose ≥105 mg/dl or HbA1c \> 6.4%.
* Major fetal anomalies.
* Intrauterine growth restriction (IUGR) before 24 weeks.
* Abnormal renal or liver function.
* Contraindications to metformin or glyburide.
* Medical treatment declined by the patient.
* Direct indication to commence insulin (initial fasting blood glucose \>= 7 mmol/l or 126 mg/dl or \>= 6 mmol/l or 108 mg/dl with macrosomia or polyhydramnios).
* Significant medical co-morbidities requiring continuous medical treatment in pregnancy.
* Non-compliance to blood glucose self-monitoring (missing 50% or more of total readings)
Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®

The purpose of this observational study is to examine the development and appearance of embryos before and after freezing following a single controlled ovarian stimulation cycle using REKOVELLE® (follitropin delta) as the recombinant follicular stimulating hormone (rFSH) for controlled ovarian stimulation. The primary objective of the study is to examine how specific factors of embryo development or appearance are related to the chance of becoming pregnant.

The ovarian stimulation protocol with REKOVELLE®, a new rFSH prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the anti-Müllerian hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective single embryo transfer (e-SET) in a frozen embryo replacement (FER) treatment where the frozen blastocyst was obtained from an IVF or intracytoplasmic sperm injection (ICSI) cycle following controlled ovarian stimulation with REKOVELLE® .
* Women are prescribed REKOVELLE® for their IVF or ICSI according to the approved label.
* Morphological measurements and clinical outcomes are available for the fresh embryos obtained from the IVF or ICSI cycle.
* Willing and able to understand Danish or English patient information.
* Willingness and ability to provide written informed consent.

Exclusion Criteria:

* Patients with any contraindication for treatment with REKOVELLE® for controlled ovarian stimulation.
* Patients with contraindication for undergoing assisted reproductive technologies (ART) such as an IVF or ICSI cycle.
* Oocyte donors.
Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women

The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).

Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.

Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.

The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Nulliparous
* Singleton gestation
* Gestational age between 39+0 and 42+0 weeks
* Vertex presentation
* Modified Bishop score \<5 and cervical dilation ≤ 2 cm
* No prior cesarean or prior uterine surgery
* Resides within 30 minutes of UAB Hospital
* Access to a telephone
* Reliable transportation

Exclusion Criteria:

* Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.
* Latex allergy
* Contraindication to induction of labor
* Evidence of labor
* Fetal demise
* Fetal anomaly
* Inability to give consent (e.g., inability to read or write)
LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.

The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.

Eligibility Criteria:
Inclusion Criteria:

* Adult (above 18 years)
* With prolapsed hemorrhoids (grades III or IV)

Exclusion Criteria:

* Complicated hemorrhoid
* Coexisting perianal disease
* Previous perianal surgery
* Unfit for general anesthesia
* Pregnancy
* History of bleeding tendency
Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients

The purpose of this study is to evaluate the effect of pain relief after infusion of ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo (0.9% normal saline).

Patients were randomly assigned to two groups, On Day 1,each subject was to undergo laparoscopic cholecystectomy under general anesthesia. Anesthesia will be induced with fentanly (2-4ug/kg), propofol TCI (4ug/ml), rocuronium (0.6mg/kg), and maintaine with remifentanly(0.1-0.3ug/kg.h) , and propofol TCI (3-5ug/ml). At the end of the operation before wound closure, patients were randomized 1:1 to receive ropivacaine or placebo. In study group all wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. All anesthetics will be stopped when wound infiltration completed. Patients will be send to PACU for monitor a while then back to ward. Record of pain intensity evaluation and rescue analgesic medication consumption were to continue through 48hours after administration of study drug. Pain intensity will be assessed by using a 0-10 point VAS scale. VAS-rest and VAS-coughing were recorded at the baseline ,2,4,6,8,12,18,24,48 hours. Postoperative Rescue analgesia consisit of Parecoxib Sodium 40mg be given by a nurse on requst of the subject to a maximum of 80mg per day.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, and any race, Age≥18 years at the screening visite.
* ASA physical status I to II.
* Scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
* Famale subjects must be without pregnancy.
* Ability to provide informed consent, adhere to the study visite schedule, and complete all study assessments.

Exclusion Criteria:

* Boss mass index \>35kg/㎡
* Under intravertebral anesthesia and/or epidural analgesia
* Under postoperatived patient-controlled epidural analgesia (PCEA) and postoperative intravenous analgesia(PCIA).
* Inability to understand and use the visual analog scale (VAS)
* Currently pregnant,nursing,or planning to become pregnant during the study or within one month after study drug administration.
* Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3months,or non-opioid pain medications more than 5 times per week.
* Proven or suspected allergy to local anesthetics ,NSAIDs and opioids .
* Use of any NSAIDs including selective COX-2 inhibitor , opioids or other analgesic agents within 3days of surgery.
* History of suspected or known addiction to or abuse of drugs or alcohol within the past 2 years.
* Current acute or chronic medical or major psychiatric disease that,in the opinion of the investigator ,would interfere with the evaluation of study drug efficacy or safety.
* Any other subjects were not suitable to this study in the opinion of the investigator.