cyrilzakka/clinical-trials huggingface dataset:
Monitoring of Bone Free Flaps With Microdialysis

Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone flaps, and they all described the position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue is not always the reflect of bone vascularisation.

The aim is to study the feasibility of a follow up of microanastomosed bone flaps with microdialysis. To reach this goal, investigators perform a clinical prospective research project untitled MTM project

In addition to our classical clinical monitoring, bone microanastomosed flaps for reconstructive facial surgery will be monitored with CMA 70 catheter directly positioned in bone tissue.

The monitoring is recorded during 5 days. Glucose, lactate , pyruvate , glycerol rates will be analysed :

* every hour at day 1,
* every two hours at day 2,
* every three hours at day 3,4 and 5.

Data are managed with Labpilot software.

Eligibility Criteria:
Inclusion Criteria:

* head and neck reconstruction with iliac crest or fibula free flaps
* informed consent obtained

Exclusion Criteria:

* reconstruction with other types of free flaps
The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age

There is a big change in our understanding of aging in recent years. Recent researches has revealed clock-like patterns of epigenetic change across in humans. The aging involves a timed epigenetic reprogramming. However, this biological clock which ticks in our DNA is affected by our experience, diet, stress, etc. and it could be changed by experience and life style potentially.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in ELOVL2-AS1 gene in saliva samples using a next generation sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy population

Exclusion Criteria:

* Chronic diseases
Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain

The aim of this study was to determine the validity, reliability and sensitivity of the Cognitive Exercise Therapy Approach Scale in patients with neck pain.

According to the power analyzes 199 neck pain patients will be taken to the study.The study will be initiated after the approval of the Ethics Committee of the Eastern Mediterranean University Faculty of Health Sciences. After informing about the content of the study, individuals who want to participate in the study will be asked to sign the informed consent form. In order to evaluate the validity and reliability of the BETY scale in the study, the same individuals will be given a test-retest with 1 week intervals. In these tests, the Neck Disability Index (NDI), Arm Shoulder and Hand Problems Questionnaire (DASH), Short Form-36 (SF-36), Hospital Anxiety and Depression Scale (HADS) and BETY scale will be applied.In order to assess the sensitivity to change, 44 individuals will be asked to re-fill the forms after the traditional physiotherapy program for neck pain, which will be administered 10 sessions. For 2 weeks, a routine exercise program consisting of 20 minutes of conventional TENS, 20 minutes of hotpack, 8 minutes of therapeutic ultrasound and isotonic, isometric, stretching and relaxation exercises will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18-65 years
* Neck pain VAS out of 3 and above which individuals
* Individuals who have neck pain for more than 3 months

Exclusion Criteria:

* Patients with previous neck surgery history
* Not willing to participate in the study
* Attract trouble understanding for filling scale
Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).


Eligibility Criteria:
Inclusion Criteria:

* 23 0/7- 29 6/7 weeks gestational age
* Postnatal age ≥ 14 days
* Requiring FiO2 ≥ 0.25 to keep SpO2 90-95%
* Parental informed consent

Exclusion Criteria:

* Severe congenital anomalies that may affect pulmonary or neurosensory development
* Severe CNS pathology that may alter respiratory control function
Cardiovascular Prevention for Persons With HIV

This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with HIV infection).

Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.


Eligibility Criteria:
Inclusion Criteria:

* HIV Infection with viral load 'undetectable' while taking antiretroviral therapy
* Age ≥40
* Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy

Exclusion Criteria:

* Known cardiovascular disease or Framingham risk score (FRS) ≥20%
* Blood pressure ≥140/90
* LDL cholesterol ≥160 (with FRS \<10%), or ≥130 (with FRS 10-20%)
* Currently taking, or has a medication contraindication to take, a 'statin', an ACE inhibitor, or an angiotensin receptor blocker medication
* Cirrhosis or plasma ALT/AST levels \>2x upper limit of normal
* Chronic kidney disease and a creatinine \>2.0mg/dL
* Triglycerides \>500mg/dL
Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.

A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.

A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).

Eligibility Criteria:
Inclusion Criteria:

1. Children ranging in age from 6 to 8 years.
2. Healthy children with no contraindications of use of local anesthetics.
3. Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I)
4. Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections.

Exclusion Criteria:

1. Uncooperative children or with intellectual or physical disabilities or medical conditions.
2. Children with acute pain or emergency visits.
3. Children with previous negative dental experience.
4. Children receiving premedications or analgesics 48 hours before testing.
5. children/parents not willing to participate.
Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors

Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility Criteria:
Inclusion Criteria:

* symptomatic brain metastases from solid tumors
* age \> 18 years
* ECOG performance status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region
Unraveling Active Ingredients of Neurorehabilitation: Investigating Cortical Activity During Task-oriented Exercises

The driving idea of this project is to use new imaging techniques during 0functional movements to study relearning during a typical rehabilitation session.

The novelty of this project is to move from studies inquiring changes in brain activity patterns before and after rehabilitation toward a paradigm in which cortical activity is studied during the execution of the exercise. This would allow better understanding of cortical mechanisms underpinning functional improvements.

The project builds on preceding studies, partially funded by FISM, from the three research units involved in this project, aimed at assessing the impact of rehabilitation on mobility and balance and at assessing the effects of neurorehabilitation on brain plasticity. In this study, we will include 40 healthy subjects and a sample of 20 consecutive People with Multiple Sclerosis (PwMS), and we will investigate brain cortical activity during a typical session of task-oriented exercises. In specific, participants will undergo a treadmill training in which they will be required to keep their trunk and head stable in space using a biofeedback device. To study the effects of the session in improving dynamic stability, Head/trunk movements will be registered by inertial measurement units, while cortical activity will be concurrently assessed by functional near-infrared spectroscopy (fNIRS).

The first phase of the project will include healthy subjects and will be useful to understand the main cortical areas involved in the proposed motor tasks, in order to design the appropriate montage and protocol for fNIRS acquisition in PwMS. Finally, the analysis of the possible differences in cortical activation during different experimental conditions (e.g., biofeedback rehabilitation) in healthy subjects and PwMS will serve to develop a model for neurological rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* subjects between 18 and 60 years of age,
* diagnosis of MS (McDonald criteria, Thompson et al, 2018), stable disease course without worsening more than 1 EDSS point over the last 3 months, EDSS between 3 and 4.5 points,
* healthy right-handed volunteers,
* able to release a written informed consent.

Exclusion Criteria:

* Unable to comprehend the aims of the study and to follow test instructions;
* Diagnosis of major depression (DSM-5);
* Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
* Cardiovascular diseases;
* Severe visual impairments interfering with the execution of the protocol;
* epilepsy;
* intake of neuroleptic and antiepileptic drugs.
OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects

The primary objectives are

* to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function.
* to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone

Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets (OxyPR) alone to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function and to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation compared to subjects taking OxyPR alone.

Eligibility Criteria:
Inclusion criteria:

* Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid therapy.

Exclusion criteria:

* Females who are pregnant or lactating.
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study
Enhanced Stress Resilience Training for Critical Care Nurses

Job stress and burnout are significant problems affecting physical health, emotional well-being, job performance, and retention of nurses. Enhanced Stress Resilience Training (ESRT) is a theory-driven, evidence-based intervention to increase stress resilience and decrease burnout among clinicians. This study is a randomized waitlist-controlled trial to examine the efficacy, feasibility, and long-term sustainability of the 5-week ESRT intervention to improve psychosocial and occupational well-being of critical care nurses.

The critical care setting is a stressful work environment where nurses provide intensive care to patients with life-threatening conditions. Regular job stress from the complex and fast-paced critical care work environment has been further intensified during the COVID-19 pandemic, which resulted in unprecedented challenges to health systems and has affected psychosocial and occupational wellbeing of healthcare workers. High or chronic job stress that is not properly managed can lead to burnout, which is characterized by emotional exhaustion, depersonalization, and decreased personal accomplishment. Burnout has negative impacts on physical and mental health (e.g., fatigue, anxiety, depression, sleep disorders), job performance or productivity (e.g., absenteeism, presenteeism), quality of care and patient care outcomes. Burnout also negatively affects nurses' retention and job turnover. The global prevalence of burnout among nurses ranges from 0.1% to 47.8% (pooled prevalence 11.2%) and critical care nurses are reported to have the highest prevalence of burnout (14.4%) among all specialties. Therefore, there is a substantial need to address burnout and promote occupational wellness of critical care nurses. Enhanced Stress Resilience Training (ESRT) is a theory-driven, evidence-based intervention developed by UCSF Associate Professor of Surgery, Dr. Carter Lebares aimed at increasing stress resilience and decreasing burnout among clinicians. The purpose of this study is to examine the efficacy, feasibility, and long-term sustainability of the 5-week ESRT intervention to improve psychosocial and occupational well-being among critical care nurses. The study will conduct a randomized waitlist-controlled trial among 100 UCSF critical care nurses.

Eligibility Criteria:
Inclusion Criteria:

* Adult critical care nurses employed at UCSF Health.

Exclusion Criteria:

* Those who cannot commit to participation in all five ESRT sessions
* Temporary travel nurses.
The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma

Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of the investigators is to determine the prognostic value of ECLNI in a prospective consecutive series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998 and 2005.

Presence and extent of extracapsular lymph node involvement (ECLNI) will be scored by reviewing all original pathological slides.

ECLNI is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue.

Observers: 1 experienced board-certified GI pathologist, blinded for follow-up results.

Follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's GP/gastroenterologist in November 2007.

Statistical analysis:

* Common closing date: 1/11/2007
* Kaplan-Meier survival analysis (Log-Rank, Wilcoxon)
* Cox logistic regression (uni/multivariate)

Eligibility Criteria:
Inclusion Criteria:

* DPAC
* Primary resection

Exclusion Criteria:

* Positive section margins
* non DPAC, other tumor
* Postoperative mortality
* Neoadjuvant chemo/radiotherapy
Cancer and Mild Cognitive Impairment Dyadic Intervention

The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study


Eligibility Criteria:
Inclusion Criteria:

Patient inclusion criteria include:

1. Patients with Stage I-IV breast, colon, rectal, or lung cancer (diagnosed within two years); age 65 or older.
2. Participants must be living at home (either in her/his own home).
3. Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
4. Exhibit Mild Cognitive Impairment/Concerns
5. Have an informal family caregiver.

Inclusion Criteria:

(Partner or family member) inclusion criteria include:

1. Caregivers are 18 older.
2. Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
3. Either co-reside with the patient or spend at least 3-4 hours day caregiving.
4. Not exhibit cognitive impairment.

Exclusion Criteria:

1. Participant has visual or hearing impairments that preclude participation.
2. Participant has dementia and do not have the capacity to participate.
3. Have a serious untreated psychiatric illness as documented in medical chart review.
4. The patient and the caregiver score less than a 3 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) on a scale 0 to 10 to screen for distress. At least one dyad member must experience distress.
Sheffield Multiple Rib Fractures Study:

An observational study to derive clinically relevant and predictive rib fracture classification systems, based on retrospective and prospective cohorts, incorporating assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation

The aim of this study is to derive radiology-based classifications of rib fractures and to test whether such classifications have a value in the prediction of clinical outcomes and patient reported outcome measures. The first aspect of work is to analyse existing radiology investigations (plain chest radiography (CXR) and derive classifications of rib fractures that, in the retrospective cohort of operated and non-operated cases, could have potential value in the guidance of management and prediction of clinical outcomes. The second aspect will be to evaluate the feasibility of collection of Patient Reported Outcome Measures in patients suffering multiple rib fractures, which will be used to assess the impact of the radiological classifications. The indications for surgery will remain according to current clinical practice and the management algorithms that have been developed previously in the department.

Eligibility Criteria:
Inclusion Criteria:

* Multiple simple rib fractures
* Flail chest

Exclusion Criteria:

-
Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants

This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR

STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children).

PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).

SECONDARY ENDPOINT:

* To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
* To compare growth and nutritional status of the 2 groups by randomized arm.
* To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (\< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed.
* To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding).

DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months.

INCLUSION CRITERIA

* Weight at birth ranging: 700 - 1501 grams;
* Gestational age up to 25 weeks and 6 days;
* Written informed consent from parents or guardians

EXCLUSION CRITERIA

* Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
* Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
* Pre-existing cutaneous disease not allowing the placement of the probe


Eligibility Criteria:
Inclusion Criteria:

* Weight at birth ranging: 700 - 1501 grams;
* Gestational age up to 25 weeks and 6 days;
* Written informed consent from parents or guardians.

Exclusion Criteria:

* Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
* Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
* Pre-existing cutaneous disease not allowing the placement of the probe
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
* Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

* Pregnant or lactating women or intending to become pregnant
* Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
* Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
* Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk