cyrilzakka/clinical-trials huggingface dataset:
Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery

The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.

We propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection. This study is to be conducted by the Department of Obstetrics at University Hospital. The intervention being studied will be the continuation of cephalexin and metronidazole for 48 hours. The primary outcome measure will be the development of infectious morbidity, including wound infection and endometritis, in the postoperative period.

In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA filtration and positive air pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery as well as general OR traffic will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An antimicrobial, adhesive drape will be used. Prior to skin incision, cefazolin will be administered.

All patients to be considered for recruitment to this study will be undergoing delivery at University Hospital. Patients with an elevated BMI \> 30 kg/m2 who undergo cesarean section will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30kg/m\*2
* Delivery via cesarean section
* consent to participate
* age 13 or older

Exclusion Criteria:

* known immunodeficiency syndromes
* non-English speaking
* known allergy to cephalosporins or metronidazole
Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome

In this proposal, the investigators wish to investigate, identify and validate potential biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.

In this proposed project, we will focus on the identification of potential biomarkers in EBC with ability to predict development of multi-organ failure. Currently, no tools could be used to evaluate the effect of mitochondrial dysfunction in sepsis. All the human studies discussing mitochondrial dysfunction in sepsis use tissue biopsies as study materials. Repeated tissue biopsy is invasive and not applicable. EBC could be collected non-invasively and conveniently. A study has demonstrated the use of metabolomic technologies in mitochondrial diseases. We believe that the metabolomic biomarkers of EBC could be used to demonstrate mitochondrial dysfunction in lungs and respiratory tracts of septic patients. Such metabolomic biomarkers may also reflect similar on-going mitochondrial dysfunction in other organ systems, and could potentially become a novel diagnostic tool and a therapeutic target in future sepsis therapy.

Eligibility Criteria:
Inclusion Criteria:

* above 20 years old
* admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube

Exclusion Criteria:

* pregnant
* active malignancy
* in an immunosuppressed status such as HIV disease, neutropenia, being treated with immunosuppressive agents
* expected to have an unavoidable very short life expectancy after admission, i.e., \< 3 days
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.

The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Rutherford Clinical Category 2-5
* The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)
* Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery
* TASC II Class A to D Lesions
* de novo lesion(s), non-stented or stented restenotic lesion(s)
* Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation
* Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3)
* A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication
* Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use
* At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure)

Exclusion Criteria:

* Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
* Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)
* Life expectancy of \< 1year
* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study
* Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
* Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel
Effects of a Comprehensive Patient-centered Health Service in Cystic Fibrosis (VEMSE-CF)

For the Project VEMSE-CF, a comprehensive patient-centered outpatient health service model was developed offering focused interventions in different areas. These included patient education, as well as nutritional and exercise counselling. Special emphasis was given to the psycho-social services. The implementation was supported by a case manager. The model was implemented in three German CF-Centers. For evaluation, Patient data from 13 additional German CF-Centers offering standard care was used as comparison. In total, 153 patients in the Intervention Group and 163 control patients aged 5-52 years contributed data. The primary endpoint was the number of BMI- and FEV1-measurements over 24 months. Secondary endpoints included mortality, lung transplantation, FEV1, BMI, adherence to therapy, Quality of life, and mental stress.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of Cystic Fibrosis - written informed consent
* intervention group: care in one of the 3 CF-centers
* control group: care in one of the 13 control CF-centers

Exclusion Criteria:

* post lung Transplantation
* listed for lung Transplantation and planned inpatient stay for more than 4 weeks
A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of schizophrenia
* Clinical stability for 16 weeks (4 months) prior to randomization
* Antipsychotic treatment stability for the past 12 weeks prior to randomization
* With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

* Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
* Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
* Patient has a body mass index (BMI) of \<17 or \>40 kg/m2, respectively
* Diagnosis of mental retardation or severe organic brain syndromes
* In the investigator's judgment, a significant risk of suicide or violent behavior
Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Transfusion-Dependent β-Thalassemia (TDT)

This is a single-dose, open-label study in pediatric participants with TDT. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (CTX001).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of TDT as defined by:

  * Documented homozygous or compound heterozygous β-thalassemia including β-thalassemia/hemoglobin E (HbE). Participants can be enrolled based on historical data, but a confirmation of the genotype using the study central laboratory will be required before busulfan conditioning
  * History of at least 100 mL/kilograms (kg)/year of packed RBC transfusions in the prior 24 months before signing of consent (or the last rescreening for patients going through repeat screening) or, for participants initiating transfusion therapy \<24 months before signing of consent, requirement for packed RBC transfusion at least every 3 to 4 weeks for ≥6 months
* Eligible for autologous stem cell transplant as per investigator's judgment.

Key Exclusion Criteria:

* A willing and healthy 10/10 human leukocyte antigen (HLA)-matched related donor is available per investigator's judgement
* Prior hematopoietic stem cell transplant (HSCT)
* Participants with associated α-thalassemia and \>1 alpha deletion, or alpha multiplications
* Participants with sickle cell β-thalassemia variant
* Clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the investigator

Other protocol defined Inclusion/Exclusion criteria may apply.
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35kg/m2 (inclusive)
* For females, postmenopausal, non-lactating, and non-pregnant

Exclusion Criteria:

* History or presence of clinical significant disease
Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout (BURNOUT ADVICE)

Burnout syndrome has been recognized as a mental illness since 2020. All workers can be affected. The consequences are multiple and often serious, ranging from stoppage of work to depression or even suicide. According to a 2019 survey by Malakoff, 56% of employees are in "professional or personal fragility", but the statistics are incomplete.

In the medical community, the burnout rate is doubled compared to the general population.

The diagnosis of pre-burnout can precede a burnout by several months, an early treatment can then reduce complications and improve the quality of life at work.

On a study model on health data already carried out as part of a cancer detection application in smokers which involved 7000 users and which showed the ability to of such an application to detect curable symptomatic cancers from questionnaires (24% with application against 9% without application), we will carry out a descriptive evaluation of the use of an application to detect pre-burnout, burnout and depressive syndrome in a worker population. In the event of a risk alert of pre-burnout, burnout or depressive syndrome, the application will display a message to the user suggesting that he consult his general practitioner or put him in contact with a doctor through a teleconsultation via a dedicated platform.

This first study will assess the feasibility and acceptability of an early detection approach among professionals of a state of "fragility" (pre-burnout, burnout or depressive syndrome). Subsequently, a larger study will evaluate the effectiveness of this application for the early detection of burnout among professionals, its management and the reduction of costs for the healthcare system and society.


Eligibility Criteria:
Inclusion Criteria:

* Person aged 18 to 64
* Exercising a professional activity
* User informed of the use of this data and not objecting to it

Exclusion Criteria:

* Professionals on sick leave
Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

This research trial studies biomarkers in predicting treatment response in samples from patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

OBJECTIVES:

I. Validation of the 15-gene prognostic and predictive messenger (m) ribonucleic acid (RNA) signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed, paraffin-embedded tissue (FFPE) tumor samples.

II. Exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using LACE-Bio FFPE tumor samples.

III. Exploratory evaluation of the prognostic and predictive values of gene copy variations using LACE-Bio FFPE tumor samples.

IV. Exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.

OUTLINE:

Archived RNA and DNA samples are analyzed for gene expression, mutations, and variations by reverse transcriptase (RT)-polymerase chain reaction (qPCR), mass spectrometry (MassARRAY), molecular inversion probe assay, and microarray assays. Results are then compared with patients' clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Samples from patients treated in 4 adjuvant chemotherapy (ACT) for early-stage non-small cell lung cancer (NSCLC) pivotal trials:

  * International Adjuvant Lung Cancer Trail (IALT)
  * Cancer and Leukemia Group B (CALGB)-9633
  * CAN-NCIC-BR10
  * Adjuvant Navelbine International Trialist Association (ANITA)
* Not specified
* See Disease Characteristics
OneTouch Verio Flex System Accuracy Evaluation

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.

Eligibility Criteria:
Summary of Inclusion Criteria:

* All Subjects must be registered into the LFSS Patient Registry to participate in the study.
* Each Participant must read and sign the approved Informed Consent Form.
* Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy.

Summary of Exclusion Criteria:

\> Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.
A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery

A randomized control trial on patients undergoing laparoscopic colorectal resection in an Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application containing guidelines, information, and tailored feedback. The hypothesis is that the application will improve adherence to the ERP.

Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative morbidity and shorten length of hospital stay with no increase in readmission rates. However, poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of mobile device applications has the potential to improve patient compliance with treatment guidelines. We recently developed and pilot tested a mobile app to support an ERP for colorectal surgery which collects patient-reported recovery information and engages patients as stakeholders in their recovery process. The overall aim of this study is to estimate the extent to which the use of this mobile device app impacts adherence to postoperative ERP elements in comparison to standard preoperative education.

Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult patients with colorectal diseases planned for surgical resection.

Participants will be randomly assigned into one of two groups:

1. usual perioperative education and audit, or
2. a mobile device application for postoperative education and self-audit.

The intervention will be delivered through a tablet present at the bedside with an application which links education, recovery planning, and daily self-assessment to a plan of care. It educates patients about daily recovery milestones and track their adherence. The primary outcome will be patient adherence to postoperative enhanced recovery elements. Other targeted outcomes include self-reported recovery, satisfaction and patient activation. According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted for this trial.

Significance: This study will contribute evidence regarding the use of mobile device technology for education and the direct involvement of patients as stakeholders in postoperative recovery.

The study findings have the potential to increase patient engagement in the care pathway, which has the potential to increase compliance to pathway elements and improve postoperative outcomes.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic colorectal resection.
* Proficient in english or french

Exclusion Criteria:

* intellectual disabilities
* major simultaneous procedures
Non-closure of Alveoli After Avulsion of Wisdom Teeth

The main objective of this study is to evaluate postoperative pain (measured by visual analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a similar group of patients undergoing standard care (suturing for lower alveoli).

The secondary objectives of this study are to compare the following between the two study arms:

A. Pain at day 31 B. Operative time C. Edema D. Trismus E. The occurrence of complications F. Alveolar flap healing G. The impact of smoking on the occurrence of complications H. The consumption of analgesics and use of local pain remedies I. Impact on quality of life

Eligibility Criteria:
Inclusion Criteria:

* The patient was correctly informed about the implementation of the study, its objectives, constraints and patient rights
* The patient gave his/her free and informed signed consent
* For patients under 18 years of age, the patient's parents (or legal guardian) must have given their free and informed signed consent
* The patient must be affiliated with or the recipient of a health insurance program
* The patient is available for 31 days of follow-up
* The patient is a candidate for avulsion of all 4 wisdom teeth under general anesthesia

Exclusion Criteria:

* The patient is participating in another study
* The patient has participated in another study in the last 3 months
* The patient is in an exclusion period is determined by a previous study
* The patient is an adult under guardianship
* The patient is under judicial protection
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* For patients under 18 years of age, his/her parents (or legal guardian) refuse to sign the consent
* The patient is pregnant, breastfeeding or parturient
* The patient has a contra-indication (or an incompatible combination therapy) for a treatment in this study
* The patient is taking antiplatelet agents
* The patient is taking anticoagulants
* The patient has a coagulation disorder
* The patient suffers from immunosuppression
* The patient's wisdom teeth are in a normal, functional, healthy position
* Other orofacial surgical procedures are planned during the study period
* Active pericoronitis
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings

The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.

The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.

Eligibility Criteria:
Inclusion Criteria:

* Superficial partial thickness burns
* Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
* One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
* Burn wounds measuring \>2% - \<40% TBSA
* Patient age: \>1 - 70 years

Exclusion Criteria:

* Ventilator dependence
* Pregnancy/Lactation
* Mechanism of injury was electrical, chemical or frostbite
* Co-morbidity which may compromise healing
* Known allergy to porcine or porcine products