cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Orbactiv® (Oritavancin) for Infections Caused by Gram Positive Bacteria in a Real World Setting

This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.


Eligibility Criteria:
Inclusion Criteria:

* The participant was treated with at least one dose of oritavancin for a suspected or confirmed gram positive infection, as monotherapy or part of a broader regimen.
* At least 60 days has elapsed since the participant received the last dose of oritavancin therapy (prior to data entry into the electronic Case Report Form).

Exclusion Criteria:

* The participant received oritavancin as a part of a controlled clinical trial.
* The participant received oritavancin as a part of a Medicines Company-sponsored single or multi-centered pharmacoeconomic outcomes study.
Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.


Eligibility Criteria:
Inclusion Criteria:

* pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml

Exclusion Criteria:

* pregnancy patients with HBeAg-negative or HBV-DNA\<106copies /ml
The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)

The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.

Prospective cohort study

Survival

* Overall survival rate
* Disease free survival rate

Recurrence

* Cumulative recurrence rate

Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class A or B
* Maximal tumor size less than 5 cm
* No previous history of treatment for hepatocellular carcinoma
* Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap

Exclusion Criteria:

* Hepatocellular carcinoma in portal vein
* Hepatocellular carcinoma in hepatic vein
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)

The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease.

The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease. This assay provides a means to measure Cl- secretion across the sinus epithelium in human subjects with chronic rhinosinusitis (CRS) and test the relationship between this data and endoscopic findings of inflammation. The technique is appropriate for investigating acquired CFTR dysfunction in sinus epithelium and examining the therapeutic potential of CFTR potentiators for CRS.

Eligibility Criteria:
Patient eligibility criteria are designed to limit enrollment otherwise healthy individuals who are scheduled for standard-of-care nasal endoscopy in the clinic or sinus/skull base surgery.

Inclusion criteria:

* Age \> 18 years
* Able to give consent
* A diagnosis of CRS, as determined by the Sinus and Allergy Health Partnership criteria
* Has cultured out at least one gram negative bacteria (e.g. Pseudomonas aeruginosa, Escherichia coli, Stenotrophomonas maltophila) within the previous month
* Is scheduled for either routine endoscopic surgery or has previously undergone endoscopic surgery and presents to clinic for routine endoscopic evaluation

Exclusion criteria:

* Age \< 18 years
* Unable to give consent
* Active diagnosis of cancer, autoimmune disease, or any know immunodeficiency
* Women who are pregnant or breastfeeding
Hyperbaric Oxygen Therapy Effects on Pulmonary Functions

Prospective analysis included patients, 18 years or older, scheduled for 60 daily HBOT sessions between 2016-2018. Each session was 90 min of 100% oxygen at 2 ATA with 5 minutes air breaks every 20 min, five days per week. Pulmonary functions,measured at baseline and after HBOT,included forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow rate (PEF).

After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session.

Pulmonary function Measurements of pulmonary functions were performed using the MiniSpir testing apparatus (MIR- Medical International Research, USA). The equipment was calibrated using a 3-liter syringe before performing measurements according to the manufacturer's instructions. Measurements were performed by a trained technician. The forced expiratory maneuvers were performed as recommended by the guidelines\[13\].

The forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak expiratory flow rate (PEF) were taken as the highest readings obtained from at least three satisfactory forced expiratory maneuvers. Mean forced mid-expiratory flow rate (FEF25-75%) and forced expiratory flow rates at 25, 50 and 75% of FVC expired (FEF25%, FEF50% and FEF75%) were taken as the best values from flow-volume loops not differing by \>5% from the highest FVC.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older patients
* scheduled for 60 HBOT sessions for any indication

Exclusion Criteria:

* Active smokers were excluded but patients who quit smoking more than six months prior to inclusion were allowed in the study.
* active smoking
* severe known pulmonary disease
* chest pathology incompatible with HBOT
* inner ear disease
* claustrophobia
* other neurological conditions
* pregnancy
* previous HBOT within six months prior to inclusion
* the inability to sign informed consent.
MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

The purpose of this study is to determine whether Barium or BariumFerumoxsil is better for fecal tagging in MR colonography. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest either a contrast agent A (200 ml Barium sulphate solution 1g/ml)) four times a day or a 200 ml contrast agent B (Barium sulfate(25%) and Ferumoxil(75%)) four times a day, which will render fecal masses "invisible" on the following MR colonography. The patients are randomised to either contrast agent A or B. The examinations are evaluated by two independent blinded readers, who will rate the tagging quality of the contrast agents. The quality of tagging will be rated by a Visual Analog Scale (VAS) and Relative contrast (ReCon = Iwall - Ilumen/ Iwall + Ilumen).


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of colorectal polyps or cancer
* Referred for colonoscopy

Exclusion Criteria:

* Suspicion of IBD
* Pacemaker
* Metal in the body
* Claustrophobia
* Pregnancy
Fire Fighter Fatigue Management Program: Operation Healthy Sleep

Firefighters work some of the most demanding schedules known under highly stressful and demanding conditions. The need to work frequent extended shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. Sleep disorders are common, costly, and treatable, but often remain undiagnosed and untreated and it is likely that a significant proportion of firefighters suffer from undiagnosed sleep disorders which will further impair their sleep and exacerbate fatigue.In the current proposal, we aim to address the health, performance and safety issues related to fatigue in firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue Management Program (CFFMP) that we have termed 'Operation Healthy Sleep.'

We propose to use a station-level, randomized experimental design to test the hypotheses that implementation of a Comprehensive Firefighter Fatigue Management Program will:

1. improve the mean total sleep, alertness and cognitive performance of firefighters;
2. improve firefighter safety, as determined by:

   1. decreased rates of motor vehicle crashes;
   2. decreased on-the-job injuries;
3. improve firefighter performance, as determined by decreased response time;
4. improve firefighters' health, as determined by:

   1. diagnosis and treatment of sleep disorders
   2. improved general health indices
   3. decreased number of 'sick' days
5. improve firefighters' and families' job satisfaction and ability to cope with extended work hours.

Eligibility Criteria:
Inclusion Criteria:

* This proposal includes research involving human subjects (fire department employees).
* Active firefighters working in the study fire department will be eligible to participate in the study.
* All applicants will be considered without bias, regardless of race, ethnicity, or national origin.

Exclusion Criteria:

* Non fire department employees
The Purpose of This Study is to Determine the Frequency of Colorectal Cancer in Male and Female Endurance Athletes Between the Ages of 35 and 50

The purpose of this study is to determine the frequency of colorectal cancer in male and female endurance athletes between the ages of 35 and 50.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females 35-50 years of age
* Male and female self-reported endurance athletes, defined by at least one of the following:

  * Run at least two races of 50 miles or more
  * Run 5 races of 26.2 miles or more
* Ability to complete testing in the protocol and make study visits
* Able and willing to consent to protocol

Exclusion Criteria:

* Known or suspected history of inflammatory bowel disease, familial adenomatous polyposis (FAP), or Lynch Syndrome
* Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
* Anticipated poor compliance
* Prisoners or subjects who are involuntarily incarcerated
* Persons with decisional incapacity/cognitive impairment
* Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study
* Subject is involved with a worker's compensation, personal injury, or other legal matters related to their health
* Subject is enrolled in a separate interventional clinical trial
Staphylococcus Aureus Resistant to Methicillin (MRSA) Screening in Trauma

The main objective of this study and to know the incidence of healthy carriers of Staphylococcus aureus resistant méti- patients supported for fracture of the proximal femur .

This assessment will be made preoperatively by a nasal sampling and analysis through it by rapid Polymerase Chain Reaction method GeneXpert® .

There are 85,000 fractures of the upper extremity in France each year. This is a frequent pathology in fragile patients. The characteristics in terms of comorbidities, age, sex and survival are well known from the literature. While secondary mechanical complications to surgery, hovering around 6 to 8%, mortality at one year is very high (around 25%).

Postoperative infection after a fracture of the upper end of the femur ranges from 2 to 8% depending on the series. This complication is responsible for morbidity and excess mortality linked to the need for revision surgery, prolongation of hospitalization and antibiotic treatment.

In elective surgery, detection of Staphylococcus aureus resistant to methicillin is systematic and recommended in many countries, preoperative level of the nasal cavity. Parvizi then Goya believe that this port increased from four to nine times the occurrence of infection at the surgical site.

Various epidemiological studies have shown the presence of Staphylococcus aureus in over 30% of patients. This prevalence is lower in the French population. An estimated 70% the proportion of Staphylococcus aureus in the periprosthetic infections, and 30% related specifically to the methicillin-resistant Staphylococcus aureus.

Today there is no consensus on what to have vis-à-vis the detection of a hand and the other hand treatment of patients.

The healthy carrier in the population overtake admitted to the trauma unit is unclear.

It is therefore necessary to know these effects among patients with multiple pathologies.

For methods of detection, the usual system and directed by swabbing and cultured with 90% sensitivity specificity of 100%. The demoyens existence of early detection as GeneXpert® Cepheid® lets get this result is in an hour with a specificity of 98% and a sensitivity of 100%.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated in the trauma unit for fractures of the proximal femur belong to a social security scheme patient

Exclusion Criteria:

* Minor patient
* Presence of abrasions
* MRSA history
* Open fracture
* Ongoing infectious process
* Patients under judicial protection , guardianship
* Pregnant or breastfeeding women
* patient refusal to participate in the study
Compare the Effect of INS Alone and Added LTRA in Treatment of SAR

It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the treatment of severe allergic rhinitis (AR) . We performed a randomized, open-label study in 46 seasonal AR subjects receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks. Visual analog scale (VAS) scores, nasal cavity volume (NCV), nasal airway resistance (NAR) and fractional exhaled nitric oxide (FeNO) were assessed before and at end of treatments as the primary treatment outcomes. Similarly, histamine, eosinophil cationic protein (ECP) and cysteinyl-leukotrienes (Cyslts) in nasal secretion and Th1/Th2 cells in nasal mucosa were evaluated as the secondary treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe seasonal allergic rhinitis
* confirmed to had a diagnosis of SAR and also shown to be sensitized to mugwort allergen
* had not received any therapies for AR or antibiotics for at least 7 days before their outpatient clinic visit prior to the study

Exclusion Criteria:

* smokers
* asthma (based on patient's history and pulmonary function tests)
* had any other chronic disease
* pregnant women
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.


Eligibility Criteria:
Inclusion Criteria:

* First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
* Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
* Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Exclusion Criteria:

* Previous immunization with any licensed or experimental pneumococcal vaccine.
* Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which in the investigator's opinion precludes the subject from participating in the study.
* Known or suspected impairment of immunological function.
Safety and Efficacy of Cariprazine for Mania

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
* Voluntarily hospitalized for current manic episode
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Women's Menstruation During the Covid-19 Pandemic

The COVID-19 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to their family. All these factors have likely resulted in significant levels of stress, anxiety, and affection of the general health

During the first wave of the pandemic, overstretched healthcare systems left health workers in hard-hit countries struggling with long working hours, fatigue, and extreme psychological stress. Rapidly vanishing supplies, national lockdown, and a feeding frenzy on the open market for personal protective equipment (PPE) led to shortages. Healthcare workers often had to care for patients with suspected or confirmed COVID-19 infection without proper training or adequate PPE. This contributed to an increased risk to healthcare workers during the initial phase of the pandemic.

Study Methods:

This is a retrospective cross-sectional study that will be conducted among healthcare professionals working in the obstetrics and gynecology department, Fayoum University Fayoum, Egypt. A survey-based study will be conducted between January 15 and March 1, 2022, using the database of Fayoum University. A self-administered online survey consisting of 80 questions was developed.

Eligibility Criteria:
Inclusion Criteria:

* All obstetrics and gynecology department healthcare workers who were or had been resident, physicians or consultant physicians, nurses, and paramedical healthcare active during the COVID-19 pandemic period at a designated Fayoum university hospital, regardless of gender, age, experience, and duration of employment.

Exclusion Criteria:

* Exclusion criteria:

  1. physicians who were retired or did not currently work in a designated COVID-19 hospital.
  2. Physicians from other specialties
  3. Physicians were on leave during the pandemic for various reasons.
Emotion and Cognitive Function and Brain Imaging Change in HD Patients

1. Observe the influence of entering hemodialysis treatment on the emotional and cognitive functions of ESRD patients.
2. Observe the influence of entering hemodialysis treatment on the brain structure imaging of ESRD patients.
3. Analyze and study the relevant clinical risk factors of the above-mentioned effects, and find targets for therapeutic intervention.

Select uremic patients and maintenance hemodialysis patients admitted to the Central Dialysis Room of Beijing Friendship Hospital, Capital Medical University from 2021, to collect and sort out the demographic characteristics of the patients: gender, age, clinical characteristics: primary disease, complications and Complications, body mass index (BMI), residual renal function, etc., clinical examination indicators: hemoglobin, blood calcium, blood phosphorus, blood PTH, blood albumin, URR, etc., hemodialysis treatment parameters: dialysis mode, dialyzer model, vascular access , Blood flow, etc., record the patient's emotional and cognitive function status, various clinical indicators and changes in the patient's quality of life before and after the start of treatment, and use multimodal magnetic resonance neuroimaging research sequences to analyze the changes in the patient's brain structure and function.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are new to hemodialysis treatment, and those who are on regular hemodialysis treatment for ≥6 months.
* Age ≥ 18 years old.

Exclusion Criteria:

* There was already a severe central nervous system disease before dialysis.
* Hearing and visual impairment cannot communicate or cooperate.
* Mental illness and incapacity.
* The magnetic resonance examination could not be completed for various reasons.
* Life expectancy with serious diseases is less than 6 months.