cyrilzakka/clinical-trials huggingface dataset:
The Predictive Role of C-reactive Protein to Albumin Ratio (CAR) in the Treatment of Septic Arthritis in Young Chlidren

Purpose: C-reactive protein to albumin ratio (CAR) has emerged as a novel marker of inflammation. However, almost no research has evaluated the role of CAR in septic arthritis (SA). There is currently controversy over the timing of surgery. Our aim is to explore the application of the CAR in predicting the treatment choice for SA in children under 4 years of age.

Methods: Retrospective analysis of the clinical data from children under four years of age admitted to the Department of Orthopedics at Children's Hospital of Soochow University between January 2016 and December 2022 due to SA. Patients were divided into surgery group and conservative group based on whether the patients underwent surgery. The clinical data of the two groups were compared. Multivariate logistic regression analysis was performed to determine the independent predictors for SA requiring surgical intervention. Receiver operating characteristic (ROC) curves were plotted for the independent predictive indicators, and the area under curve (AUC) was determined. The cut-off value was determined using Youden index, and diagnostic accuracy indicators such as sensitivity (SEN), specificity (SPE), positive predictive value (PPV) and negative predictive value (NPV) were calculated.


Eligibility Criteria:
Inclusion Criteria:

* (1) Meeting the aforementioned SA diagnostic criteria, regardless of the affected joint; (2) Completing routine blood and biochemical tests within 24 hours of admission; (3) No surgery or antibiotics administered prior to admission.

Exclusion Criteria:

* (1) Cases of transient synovitis, rheumatism-related diseases (JIA, etc.), simple acute hematogenous osteomyelitis, or acute exacerbation of chronic hematogenous osteomyelitis after revision of the diagnosis; (2) Postoperative iatrogenic infection; (3) Incomplete clinical data.
Cardioprotection on Chemotherapy-Induced Cardiotoxicity

The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.

The goal of this interventional study is to evaluate the protective impact of Angiotensin-converting enzyme (ACE) inhibitors versus β-blockers on the cardiotoxicity profile of pediatric patients with acute leukemia. The impact is measured by evaluation of left ventricular ejection fraction (LVEF) by 2D echocardiography at baseline and at the end of Induction phase (42 days).

Eligibility Criteria:
Inclusion Criteria:

* Willingness of the legal representative of research participant to participate in the study by giving "informed consent."
* Ability to take oral medication.
* Age 2-18 years at the time of diagnosis.

Exclusion Criteria:

* Documented allergy to cardioprotective medications
Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique

The purpose of this study is to determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings).

Healing will be determined by time to ≥90% epithelialization within 21 days of treatment. Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to standard techniques without application of skin cells (epidermal grafts = acellular) and will be measured twelve months post treatment application, ± 6 months.

Hypothesis:

The use of epidermal blister grafting by the CellutomeTM device in the treatment of superficial and mid-dermal burn wounds will demonstrate a difference in time to healing compared to burn wounds treated with standard acellular technique.

Primary objective:

Determine if the use of the CellutomeTM device will demonstrate a difference in healing time compared to standard acellular technique. Final cosmetic outcomes (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be assessed and described at 12 months ± 6 months post treatment.

Secondary objectives:

* Determine if donor sites have any visible scarring with the use of the CellutomeTM.
* Determine acute outcomes of therapy such as time to healing as assessed by ≥90% epithelialization.
* Determine chronic outcomes of therapy (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation).

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted or seen by the LVHN Burn Service with superficial to mid-dermal thickness burns will be considered for the study.
2. Age ≥18 years old.
3. Patients with a total body surface area (TBSA) burn \> 1% outside of the face, neck, feet or genitalia, where at least 2 areas are greater in size than 5x5cm2 or at least one area that is greater than 10cm2

Exclusion Criteria:

1. Pregnant.
2. Age \< 18 years old.
3. Proposed study area on face, neck, genitalia, or feet.
Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent

The purpose of this study is to assess whether the outcome of treatment with CoroflexTM Please stent is not inferior to the outcome of treatment with TAXUS stent.

To establish the effectiveness and the safety of coronary stenting with the newly developed paclitaxel-eluting balloon expandable stent (CoroflexTM Please stent, B. Bran, Melsungen, Germany), compared to the conventional paclitaxel-eluting balloon expandable stent (TAXUS stent, Boston scientific) in the treatment of coronary stenosis.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be at least 18 years of age
* Significant de novo coronary artery stenosis (\>50% by visual estimation)
* Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patents with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications:

  * Heparin
  * Aspirin
  * Both Clopidogrel and TIclopidine
  * Sirolimus, paclitaxel
  * Stainless steel and/or
  * Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled)
* Systemic (intravenous) Sirolimus or paclitaxel use within 12 months
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
* Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
* Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL
* An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
* Patients with EF\<25%
* Cardiogenic shock at entry
* Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
* Creatinine level \> 3.0mg/dL or dependence on dialysis
* Patients with left main stem stenosis (\>50% by visual estimate)
Gender Differences and Age Related Differences in Emergency Department Admission

The goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department.

Objectives: Medicine is progressively becoming aware of the clinical difference among patients who present different age, gender, and comorbidities. Our goal is to examine how often different groups of patients access the Emergency Department and for which causes, as well as their different hospitalization and death rates.

Materials and methods: The investigators will collect and analyze data from all patients evaluated at the emergency department of "Fondazione Policlinico Agostino Gemelli" and "Istituto Clinico Humanitas di Milano" from January 2014 to December 2023, the sample obtained will be divided into four groups: younger than 50 years old, 50-65 years old, 66.75 years old, older than 75; each of these groups is divided between males, females and people who do not identify with either of those genders

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 y
* Admitted to emergency department

Exclusion Criteria:

* Age under 18 y
Controlled Feeding Experiment

The purpose of this study is to determine the effect of dietary fat, in standard formulation, on the composition of the human microbiome in a prospective study of normal volunteers. Participants will be randomly assigned to either a high fat or low fat diet for 10 days. The gut microbiome will be phylotyped in fecal samples as well as in bacteria adherent to the colonic mucosa prior to, and during the course of the dietary interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is capable of giving informed consent
2. Participant is age 18 to 40 years

Exclusion Criteria:

1. Diagnosis with Inflammatory bowel disease (IBD), celiac disease, or other chronic intestinal disorders.
2. Baseline bowel frequency less than every 2 days or greater than 3 times daily.
3. Current smoker.
4. Body Mass Index (BMI) \<18.5 of \>35.
5. Diabetes mellitus (DM)
6. Diagnosis with coronary artery disease, congestive heart failure, or prior myocardial infarction.
7. History of dyslipidemia or receiving treatment for hypercholesterolemia. This will be defined as a fasting LDL \>160 mg/dL or a non-fasting total cholesterol \>200 mg/dL or non-fasting HDL\<40 mg/dl. Additionally, patients receiving drug therapy for hypercholesterolemia will be excluded.
8. Prior bowel resection surgery.
9. Contraindication to flexible sigmoidoscopy and biopsies. Patients with suppressed white blood count may be at increased risk of systemic infection following sigmoidoscopy with biopsies. As such, subjects with a white blood cell (WBC) count less than 3,500 or an absolute neutrophil count of less than 1,000 will be excluded. Patients with thrombocytopenia or with a coagulopathy may be at increased risk of bleeding complications after colonoscopic biopsies. As such, patients with a platelet count of less than 100,000 or an international normalized ratio (INR) greater than 1.2 will be excluded from the study.
10. Student or employee of any one of the investigators.
11. Pregnant women.
12. Use of antibiotics in the prior 6 months.
13. Use of antacids, non-steroidal anti-inflammatory drugs (NSAIDs), or dietary supplements in the preceding 2 weeks.
14. Use of any of the following medications in the 4 weeks prior to randomization: proton pump inhibitors (PPI), histamine receptor antagonists, narcotics, tricyclic antidepressants, anticholinergics (e.g., hyoscamine), metoclopramide, anti-diarrhea medications, laxatives.
15. HIV infection, AIDS, or other known conditions resulting in immunosuppression.
16. Allergies or intolerance to the components of the study diets.
17. Participant has experienced diarrhea within the two weeks prior to the first sigmoidoscopy. Diarrhea is defined as a change in bowel habits with an increased frequency or loose stools such that the stool could not be lifted with a fork.
18. Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
Relationship Between Health Literacy and Physical Activity in Adult Patients With Cystic Fibrosis

The purpose of this study investigation of relationship between health literacy and physical activity, anxiety and depression, adherence to airway clearance techniques in adult patients with cystic fibrosis.

The assessment will begin with demographic information then health literacy, depression and anxiety and physical activity level will evaluation with related questionnaires.

Eligibility Criteria:
Inclusion Criteria:

be between the ages of 18-65 volunteering to participate

Exclusion Criteria:

having any cardiopulmonary disease having cognitive problems being illiterate
Injured - Sport Health Armed Forces (Blessé - Sport Santé Armées): Reconstruction Through Sport in the Armed Forces

Since 2014, the armed forces have been offering injured military personnel the opportunity to rebuild their lives through sport. Sport, considered as the "DNA" of the military, thus becomes a vector of socio-professional reintegration for physically and psychologically injured soldiers.

In its 2019-2024 national Sport-Health strategy and in the Ministry of the Armed Forces' "Sport 2025" plan, rebuilding injured military personnel through sport is becoming a major focus of the new sports policy for the armed forces.

In addition to the well identified physiological benefits, sports are recognized as a way to encourage social relationships, fight stress and isolation, and promote solidarity. Sport thus contributes to the physical and mental reconstruction of the injured, promoting the phenomenon of resilience well described in the Anglo-Saxon world.

The implementation of the Reconstruction through Sport Program ("PRS") is based on the coordinated actions of the assistance units for the wounded, the French Armed Forces Health Service and the National Center for Defense Sports (CNSD), which have set up a complete sports program (discovery, leisure, competitions), adapted and evolving, regardless of the physical and/or psychological after-effects and the disability secondary to the injury.

In France, there are an increasing number of PRS-labeled sports events, such as the Military Injury and Sports Meetings, the Ad Victoriam Challenge, and internationally, the Invictus Games and the Military World Games. It should also be noted that this pathway leads some injured people to high-level competition.

No study has yet evaluated the path of reconstruction through sport for French injured military personnel initiated in 2014.


Eligibility Criteria:
Inclusion Criteria:

* French military
* Physically injured since January 1st, 2008
* Registered by a casualty assistance cell
* On duty or on long term sick leave

Exclusion Criteria:

* No physical injury
* Individuals who do not speak, understand or read French
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies

This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Written informed consent
* At least 3 unformed or watery stools in each of the 2 previous 24 hour periods.
* Confirmed diagnosis of C. difficile associated diarrhea

Exclusion Criteria:

* Pregnant or breast feeding women
* Known allergy to milk or milk products
* Other etiology of diarrhea
* Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus
* Pseudomembranous colitis
* White blood count \> 50,000
* Blood in stools
* Laxatives or motility drugs within 12 hours
* Inability to participate in adequate follow up
* Clinically unstable
* Investigator deems unsuitable
* Immune suppression (disease or treatment)
* GI surgery
* Past intestinal parasites
Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

Temozolomide provided significant and clinically meaningful benefit in MGMT gene promoter methylation glioblastoma. However, in unmethylated patients, the effect of Temozolomide is limited. The aim of this study is to compare the effect of Etoposide plus Cisplatin and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma.

60 Patients with glioblastoma were recruited for this study based on the following eligibility criteria: Age between 18 and 70, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed MGMT gene promoter unmethylation glioblastoma, no cerebrospinal fluid and distant metastatic disease. All patients had adequate hematologic, hepatic, and renal function. Patients younger than 18 years; patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities were excluded.

60 patients were randomly divided into two groups and compared the difference of efficacy between the two groups

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70,
* performance status of 0-1 (Eastern Cooperative Oncology Group performance status),
* histologically confirmed MGMT gene promoter unmethylation glioblastoma
* no cerebrospinal fluid and distant metastatic disease.
* adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* younger than 18 years;
* with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities
Urinary and Anal Incontinence in Tunisian Women

The publications on prevalence and risk factors of urinary and anal incontinence in women were performed mainly in Europe and America. Consequently, result extrapolation to Tunisian population may not be a good practice which justifies this study and demonstrates its importance.

A cross-sectional study will be conducted among female doctors and nurses randomly selected from 3 large hospitals in the center of Tunisia. The prevalence of urinary incontinence and anal incontinence will be measured using validated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Professional seniority in the current service over than 6 months
* Subject has given his consent

Exclusion Criteria:

* Resident
* Intern
* An ongoing pregnancy
* A recent birth (less than 6 months)
* A psychiatric disease
* An acute or chronic kidney disease
* Neurological disease
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial

Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.

The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.

In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are randomized into the treatment group and the control group. The follow-up is at least 24 months.

The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b) and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with an IIEF ≥ 21 (IIEF-6).

The operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles.

The Outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "International Index of Erectile Function" (IIEF) questionnaire.

The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.

Eligibility Criteria:
Inclusion Criteria:

* Localized intermediate-risk or high-risk prostate cancer cT3
* Gleason score ≥ 7 (3+4 and/or 4+3) and/or
* PSA ≥ 20 ng/ml
* intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).

Exclusion Criteria:

* IIEF \< 21
* Operations in the past 6 months which could limit the erectile function
* Erectile dysfunction in the history or current medication for erectile dysfunction
* Current involvement in another comparable study.
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients

Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Exercise training can depress tumor growth and suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and some animal studies. The purpose of this study is mainly to investigate the effects of exercise training on

1. circulating VEGF-A
2. muscle growth and function
3. Myostatin


Eligibility Criteria:
Inclusion Criteria:

* Age 40-75 years
* Advanced NSCLC
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Targeted therapy for at least 8 weeks
* Stable condition

Exclusion Criteria:

* Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
* Do not understand the verbal or written instructions
Exercise in Severe Mental Illness. The PsychiActive Project

The purpose of this randomized controlled trial is to study the effects of exercise on body weight, body composition, anthropometric and fasting blood measures, physical fitness, pulmonary function, quality of life, and lifestyle habits in patients with severe mental illness.


Eligibility Criteria:
Inclusion Criteria:

Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month.

Exclusion Criteria:

Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.