cyrilzakka/clinical-trials huggingface dataset:
Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.

The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has not been studied extensively. Subjects are being asked to participate in this study because they are scheduled for surgery and because the investigators want to study ways to improve recovery from surgery. Ibuprofen will be given several times before and after surgery. The investigators will ask questions to determine recovery and the investigators will draw blood to determine inflammatory response.

Human and animal studies suggest cyclooxygenase-inhibitors (COX-inhibitors) decrease the production of inflammatory mediators. Studies also suggest that COX inhibitors attenuate increases in corticosterone and eicosanoid levels after endotoxin injection. COX inhibitors also appear to have anticancer effects, inhibiting angiogenesis, tumor growth, and metastatic burden. These results suggest a role for IV ibuprofen in preventing untoward inflammatory responses, shortening post-surgical convalescence, improving patient satisfaction, and reducing the rate of complications occurring during the recovery from surgery. However, there are no studies that have evaluated the relationship between administration of IV ibuprofen, ensuing immunomodulation, and long-term outcomes.

Study Objective. The aim of the proposed study is to examine the effect of intravenous(IV) ibuprofen on the inflammatory response in major surgery. More importantly, the investigators will correlate changes in the concentration of inflammatory mediators with meaningful clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Adults, 18 and over, who will undergo surgery lasting longer than one hour with general anesthesia
2. Subject is non-lactating and is either:

   * Not of childbearing potential
   * Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
3. Subject is ASA physical status 1, 2, or 3

Exclusion Criteria:

1. Cognitively impaired (by history)
2. Subject requires chronic antipsychotic history
3. Subject is anticipated to require an additional surgery within 90 days after the intended surgery
4. Chronic use of steroids or opioids
5. Subject has received treatment with COX inhibitors within 3 days of study entry
6. Subject for whom opiates, benzodiazepines, and COX inhibitors are contraindicated
Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.

The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)


Eligibility Criteria:
Inclusion Criteria:

* All children from 0 up to 5 years attending to the hospital's emergency department will be evaluated for IPD.
* Diagnosis of IPD will be based on positive pneumococcal isolation in any sterile location, such us blood or spinal fluid.
Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.

This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).

Eligibility Criteria:
Inclusion Criteria:

* Primary fractures requiring fixation with cannulated screws

Exclusion Criteria:

* Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
* Secondary fractures
* Non-union fractures
* Tibial tubercle osteotomies (TTOs)
* Slipped capital femoral epiphysis (SCFEs)
* Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age
* Allergies or contraindications to screw materials
Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus

The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.

Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was made according to AASLD guidelines
* Main tumor ≥ 7 cm
* Imaging confirmed the presence of PVTT in the first branches but not
* Extend into the main trunk of portal vein
* Eastern Co-operative Group performance
* Resectable disease

Exclusion Criteria:

* Child-Pugh class B or C liver cirrhosis
* An American Society of Anesthesiologists (ASA) score ≥ 3
* Extrahepatic metastasis
* Patients had access to sorafenib.
Image Data Collection of Tanned Skin During Phototherapy Treatment Using a Multi-spectral Camera

This is a prospective, observational, single-center, image collection study. Any patient who arrived at the phototherapy clinic for the first time, regardless of this study, and is prescribed a total of 30 treatments can be included, regardless of skin or medical condition.

After consenting subjects at least 5 close-up images will be taken from the specified anatomical areas, at different angles, using the SMART camera. Additional reference images of skin that is not exposed to the phototherapy treatment will be taken with the SMART Camera. Global image of the skin using a regular high-resolution camera is optional. The images will be collected on baseline visit, at least every 3 phototherapy treatments (approximately once a week), and at the last phototherapy treatment visit. i.e., in total of at least 11 phototherapy treatment visits. Follow-up images will be taken at 1-week and 2 weeks following the last phototherapy treatment.

Images shall be taken from any anatomical area that does not consist of any marked lesions or skin conditions. All images will be non-identifying.

The SMART camera is advanced proprietary multi-spectral system camera, developed for research purposes. The SMART camera system is based on commercially available components and consists of 3 modules:

1. Camera Handpiece- Spectral module with a monochromatic camera, optics, and an array of LEDs at 7 different wavelengths.
2. Control Unit - an electronic box that powers and controls the camera. It includes electronics and a miniature computer.
3. Touch screen monitor - With user interface to operate the system When taking a photo, a series of cross-polarized monochromatic images are taken, each at different illumination color (wavelength). In total, seven images are taken with blue (450nm), teal (490nm), lime (570nm), orange (590nm), red (660nm), IR-1 (730nm), IR-2 (860nm). The total acquisition time for the seven images is 0.1sec. The images are stored in a dedicated directory on a removable hard disk in the control unit in correlation to patient ID entered through the user interface on the laptop. The number of images that can be taken is unlimited.

The camera passed the following safety tests by certified lab:

1. Check-up Safety Testing - IEC-60601-1 tests for investigational device by external laboratories according to IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards
2. LED Hazard Evaluation UV, Visible \& NIR Test, according to IEC62471 by an external certified laboratory

Eligibility Criteria:
Inclusion Criteria:

* Any patient, male or female 18 years or older.
* Patient is scheduled for 30 treatments or more of phototherapy
* Subject is capable and willing to sign an informed consent
* Subject is willing to comply with study schedule
* Subject has areas of skin that do not consist any marked lesions, hairs or skin conditions and can be captured in the study

Exclusion Criteria:

• Subjects incapable of providing an informed consent
Implementation of Quality of Life Diagnostics and Therapy

Implementation and Evaluation of Implementation of Quality of Life Diagnostics and Therapy in Individual Patients with Breast Cancer. A prospective study including 170 patients, 5 clinics and 38 general practitioners as coordinating doctors for quality of life therapies. Correlational study including several comparisons such as patients and their doctors.

Improving cancer patients' quality of life (QL) requires that QL-diagnostics, the availability of QL-enhancing treatment options and treatment decisions are being integrated into a clinical path. This description presents the development and implementation of such a clinical path in the Tumorcenter Regensburg.

The acting persons and institutions in this clinical path are the breast cancer patients, the hospitals, the family doctors or gynaecologists, and a QL-study team. Starting point is the QL-assessment either in the hospital or in doctors' practice (EORTC QLQ-C30 plus BR-23). The caring physician documents the patients' health status. Based on these two pieces of information, the QL-study team writes up a medical/QL-opinion plus therapy recommendation. This report is sent to the caring physician. The effectiveness of the therapy recommendation is assessed in the following QL-assessment. This clinical path is implemented via three interrelated methods of implementation: local opinion leaders, outreach visits, and quality circle.

A total of 38 physicians were made familiar with QL-diagnostics through outreach visits, and 12 opinion leaders were identified and convinced to support this project. The quality circle provided regular CME meetings on QL-enhancing therapy options (pain control, psychotherapy, physiotherapy, nutrition, social rehabilitation). A total of 170 QL-reports were sent to physicians. All 38 doctors found the QL-profiles comprehensible and the therapy recommendations clinically relevant. The most common QL-problems were emotional functioning, fatigue, and arm/shoulder problems.

QL-diagnostics is a new way to individualise and to rationalise patient care. It transforms the QL-concept into a decision-relevant, integral part of a clinical path that aims to provide high quality patient care.

Eligibility Criteria:
Inclusion Criteria:

* All patients with primary breast cancer in the county of Regensburg, Amberg and Sulzbach-Rosenberg in the year 2003 to June 2004 submitted by coordinating physicians who were trained in quality of life questionnaires and profiles.

Exclusion Criteria:

* Secondary breast cancer, patients who refused to participate, patients incapable of filling out questionnaires, male patients, pregnant patients, age below 18 yrs.
Dispersal Pattern for Spine Injections (Gadolinium Contrast)

This study will analyze injectate dispersal patterns after standard-of-care cervical epidural steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to characterize the pattern. Although these procedures are performed with high frequency under the assumption that injectate remains localized to injection site, no peer-reviewed studies have validated this assumption. Comprehensive characterization of injectate dispersal patterns will provide important data regarding safety, as well as diagnostic and therapeutic potential of cervical epidural steroid injections.

Epidural steroid injections have long had an impact in the treatment of various spine-related conditions, particularly radiculopathy. The efficacy of epidural spinal injections has been attributed to the anatomic location reached by the injectate. Cervical epidural steroid injections are also used as an injury location indicator. This application is based on documenting pain relief after injection into a specific location in the cervical spine. Both the diagnostic and therapeutic applications for epidurals assume that the injectate remains local to the injection site in order to have its effects. However, in a recently completed study, the investigators group documented substantial diffusion of injectate after lumbar epidurals used computerized tomography (CT) assessments.1 Based on the exposure to ionizing radiation associated with CT along with the superior imaging specificity and sensitivity of MRI, the investigators are shifting their imaging modality to MRI for future studies. The proposed study is designed to evaluate the use of gadolinium and MRI to assess nature and amount of diffusion of injectate in the cervical region after standard-of-care epidural injections. To the investigators knowledge, this will be the first study to critically assess this common procedure in order to evaluate safety and efficacy in a clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* Cervical radiculopathy patient as identified by principle investigator

Exclusion Criteria:

* Patients unable to give consent or comply with rehabilitation process
* Pregnant
* Co-morbidities such as infection, malignancy, myelopathy or an uncontrolled medical condition
* Allergy to injectate
* Anticoagulative state
* Severe claustrophobia
* Non-MRI compatible pacemaker, neurostimulator, bladder stimulator or other mechanical device
* Renal disease that would cause the patient to be at an increased risk of complication of receiving the contrast agent
Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome

Infective endocarditis is a complex infection that can be life-threatening. These infections also cause anatomical lesions that can be severe. Their management is complex and involves several disciplines: cardiology, bacteriologists, infectious diseases specialists, radiologists, nuclear medicine specialists, cardiac surgeons, neurologists, pharmacologists, etc. The incidence of Enterococcus faecalis endocarditis is increasing due to the aging of the population and the disappearance of rheumatic fever. The adequate management of these infections is complex and relies on the prolonged administration of high-dose antibiotics, classically the combination of amoxicillin and ceftriaxone. In the context of Streptococcal endocarditis, the impact of increasing the Minimum Inhibitory Concentration (MIC) of amoxicillin on patient mortality has been demonstrated but no study has yet examined the impact of increasing the MIC of amoxicillin on the outcome of patients treated for Enterococcus faecalis infective endocarditis.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age with a diagnosis of Enterococcus faecalis infective endocarditis based on Duke criteria
* Patient hospitalized in one of the participating centers
* French-speaking patient

Exclusion Criteria:

* Patient with suspected infective endocarditis who does not meet Duke criteria
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of their data for this research
Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction

This prospective study will include patients taking or having taken bisphosphonates and needing dental extractions.

The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth extraction sites.

In the test group (PRF) and in the control group (no PRF), we use the same atraumatic extraction protocol associated with the same antibiotic procedure.

Dental extractions are the main cause of jaw osteonecrosis in patients taking oral or iv bisphosphonates.

This prospective randomized study will include a cohort of 100 patients treated with bisphosphonates (for benign or malignant conditions) and requiring dental extractions (non-retainable teeth for infectious, traumatic or parodontal reasons). 50 patients will benefit of PRF placement in the tooth extraction site (group 1) while 50 patients do not (group 2).

The rest of the procedure will be the same in the 2 arms. In the literature, studies suggest a benefit from a long term antibiotherapy before and after tooth extraction. Extraction procedure should be the least traumatic as possible.

The main objective of our study is to assess, after tooth extraction, the contribution of PRF in the prevention of jaw osteonecrosis induced by bisphosphonates.

A follow-up period of one year after extraction is indicated.

Eligibility Criteria:
Inclusion Criteria:

* patients taking bisphosphonates whatever the indication, the type, the administration and the duration of treatment (we include patients taking or having taken bisphosphonates, even several years ago)
* And who need tooth extraction (not recoverable in conservative dentistry and symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth fracture).

Exclusion Criteria:

* pregnant women
* younger than 50 years old
* jaw's radiotherapy
* history of jaw osteonecrosis
* jaw metastasis from an other cancer
Effects of Vibration Foam Rolling After Muscle Damage

Purpose: To compare the effects between non-vibration foam rolling (NVFR) and vibration foam rolling (VFR) on visual analogic scale (VAS), pressure pain threshold (PPT), oxygen saturation (SmO2), counter-movement jump (CMJ), and hip and knee range of movement (ROM) after induction of muscle damage through eccentric acute-exercise using inertial flywheel.

Methods: Thirty-eight healthy subjects (males n=32 females= 6, age 22.2±3.2 years) were randomly assigned in a counter-balanced fashion to either a VFR or NVFR protocol group. All subjects performed a 10x10 (sets x reps) eccentric squat protocol to induce muscle damage. The protocols were administered 48-h post-exercise, measuring VAS, PPT, SmO2, CMJ and ROM, before and immediately post-treatment. The technique of treatment was repeated on both legs for 1 min for a total of 5 sets, with a 30-s rest between sets.

Muscle damage was induced with overload eccentric training using inertial flywheel (2.7-kg flywheels with a moment inertia of 0.07 kg m-2). Immediately after baseline measures, subjects performed 10 sets x 10 repetitions parallel squats using a gravity-free training device flywheel with 2 minutes of recovery between sets. The squat exercise was chosen as basic movement because of its similar muscles recruitment to many athletic movements patterns. Furthermore, the squat exercise is one of the main exercises used to improve the lower-body strength. The required technique was demonstrated to all subjects before beginning the eccentric session, and they were coached during the protocol to be sure adequate technique and maximal effort in each repetition were maintained. All participants performed 5 min on a treadmill to warm up before performing the eccentric bout.

Description of the foam roller intervention The foam-rolling technique was based on a previously published protocol. In both protocols, the technique was repeated on both legs for 1 min for a total of 5 sets, with a 30-s rest between sets. The cadence for both techniques (NVFR and VFR) was fixed at 3:4 using a metronome.

Using a protocol adapted from previous study, subjects began in the plank position with the foam roller at the most proximal portion of the quadriceps of both legs, with as much of their body mass as possible on the foam roller.

Non-Vibration Foam Rolling (NVFR) Group: subjects performed the FR protocol using a custom-made foam roller composed of a polystyrene foam cylinder (15-cm diameter × 35-cm long).

Vibration Foam Rolling (VFR) Group: subjects performed the same protocol using a foam roller with vibration (frequency: 18 Hz) composed of a polystyrene foam cylinder (15-cm diameter × 35-cm long).

Eligibility Criteria:
Inclusion Criteria:

* All subjects were free from musculoskeletal disorders in the last year. All subjects were asked to abstain from unaccustomed exercise, all medications and dietary supplements 72 hours before baseline measurements, during the experimental period and post-treatment

Exclusion Criteria:

* Subjects with symptoms or pathology,