cyrilzakka/clinical-trials huggingface dataset:
Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the development of diabetic retinopathy are incompletely understood and include alterations in bone marrow derived vasculogenic cells called "endothelial progenitor cells".

Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and hypertriglyceridemia. In a trial conducted in type 2 diabetic patients, the drug fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the mechanisms that drive the development of this complication.

Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC levels in diabetic patients with retinopathy, compared to placebo.

Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the development of diabetic retinopathy are incompletely understood and include alterations in bone marrow derived vasculogenic cells called "endothelial progenitor cells".

Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and hypertriglyceridemia. In addition to lowering triglyceride-rich lipoproteins, PPAR-alpha agonism with fenofibrate has several additional molecular benefit on the vessel wall, such as reduction of inflammation. In a trial conducted in type 2 diabetic patients, the drug fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the mechanisms that drive the development of this complication.

Preliminary data of ours on the effects of fenofibrate on cultured EPC show that this drug has the potential to improve EPC and, consequently, may benefit patients with retinopathy.

Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC levels in diabetic patients with retinopathy, compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes
* Diabetic retinopathy
* Age 18-70
* Both sexes

Exclusion Criteria:

* Age \<18 or \>70 at enrollment
* Hereditary muscle disorders
* Uncontrolled hypothyroidism
* Elevated alcohol consumption
* Renal failure
* Hepatic failure
* Allergy to fenofibrate or excipients
* Acute / chronic pancreatitis
* Pregnancy and lactation.
Study on the Role of Gamma Delta T Cells in Sepsis Immunosuppression and Its Molecular Mechanism

The purpose of the study is to evaluate the status and function of gamma delta T cells in peripheral blood of sepsis patients.

Sepsis therapy is a prominent problem of the modern critical care medicine,and improving the level of sepsis treatment by immune intervention measures is a hot research topic with close attention.Gamma delta T cells is considered as one new T lymphocyte subset in recent years,which playing an important role in resistance to infection,anti-tumor and immune regulating function in the body.First,we played attention to the status and function of gamma delta T cells in peripheral blood of sepsis patients including differentiation marker,subtype and production of related cytokine,and then the molecular mechanism of insufficient gamma delta T cells.At the same time the responsibility of gamma delta T cells of sepsis patients to certain bacteria and viral antigen and the regulation of gamma delta T cells on other natural immune cells including NK cells and mononuclear cells were studied to identify the status and role gamma delta T cells in sepsis immunosuppression by culture in vitro.Further we studied the effect of specific stimulants on proliferation and activation of gamma delta T cells in patients with sepsis and also anti-infection acquired by gamma delta T cells,expecting as an entry point to explore new treatment strategy to sepsis.

Eligibility Criteria:
Inclusion Criteria:

* clinical symptoms of severe sepsis and septic shock
* age over 18 years

Exclusion Criteria:

* preexisting autoimmune disease
* patients received immuno-suppressive treatment in the previous 6 months
* patients with chronic infection,e.g.tuberculosis,hepatitis or HIV infection,etc.
* pregnancy
Driving After Shoulder Surgery

Patients undergoing a shoulder arthroplasty or rotator cuff repair will be enrolled in the study. Patients will be asked to undergo driving simulator assessments post-operatively in ATI Physical Therapy for up to 12 weeks after surgery in order to determine when it may be safe for them to return to driving. Additional assessments include patient-reported outcomes, range of motion, and strength measures, which are all standard of care. Study participation concludes when the patient passes the driving simulator test.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon
2. Patients receiving physical therapy from ATI Patewood clinic
3. Must be able and willing to complete all study assessments and to be followed for the full course of the study.
4. Must be able to read, write and follow instructions in English.
5. In the opinion of the investigator, is that they subject is competent to participate in study activities
6. Prior to injury, patient was routinely driving.

Exclusion Criteria:

1. Prior shoulder surgery in the last 90 day
2. Individuals with a history of any underlying neurological conditions
Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound

Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone.

Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP, who are unable to open their eyes.

Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone. During the robotic surgery there are two theories explaining the increase of IOP, first, gravitational forces increase central venous pressure which in turn affect orbital venous pressure and increase IOP. Second, intraperitoneal carbon dioxide causes increased choroidal blood volume which may result in IOP increase. One study reported that low end tidal carbon dioxide was a significant predictor of the IOP increase. Continuous absorption of carbon dioxide from peritoneum and increased pressure on diaphragm results in lower delivered tidal volumes and subsequently increased arterial carbon dioxide levels leading to increased choroidal blood flow and increased IOP.

Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP, who are unable to open their eyes. It can also be used for serial examination and follow-up of treatment success. They also mentioned that, it is necessary to conduct a prospective study with a larger sample size, to evaluate if there is agreement between measurements using a tonometer and measurements of the ACD using ultrasound. In addition, it is essential to determine the cut off normal ACD for evaluation of IOP.

Eligibility Criteria:
Inclusion Criteria:

1. ASA class I-III
2. Urological cancer patients under going robotic assisted surgeries.
3. Gastrointestinal cancer patients under going robotic assisted surgeries,
4. Gynecological cancer patients under going robotic assisted surgeries,

Exclusion Criteria:

1. ASA class IV and above
2. Patients with a history of glaucoma.
3. Patients with corneal disease, retinal vascular disease.
NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer

This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.

Squamous cell carcinoma of the anus (SCCA) is a rare disease with less than 200 new cases in Denmark and Sweden each year and approximately 100 new cases in Norway and Finland but with increasing incidence. Primary treatment is chemo-radiotherapy (CRT) comprising high dose IMRT based radiation therapy with combination chemotherapy of 5-FU and Cisplatin. Overall treatment response is good in small tumors, but less pronounced for high-risk tumors.

In absence of complete pathological response after CRT or local recurrence, patients are evaluated for. salvage surgery. The importance of R0 resection on overall survival has been described in several studies. It is suggested that early detection of treatment failure and recurrences increases the chance of possible curative surgery (R0-resection) and thereby overall survival.

A follow-up program has 3 purposes

1. To detect lack of complete response to primary treatment
2. Early detection of local or distant recurrences
3. Describing and managing late morbidity

Purpose:

The main purpose of this follow-up study is to investigate if circulating tumor tDNA can improve detection of early treatment failure or recurrences thereby assisting in increasing the potential for cure. Secondly, to provide evidence for use of imaging and third objective is to establish early intervention against late morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with SCCA eligible for definitive (chemo)radiotherapy
* ≥ 18 of years
* Written and oral consent

Exclusion Criteria:

* Conditions that will contraindicate blood samples
* Conditions that will contraindicate a PET-CT scan.
* Potential lack of compliance to standard FU program and study participation.
Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner.

Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients.

Eligibility Criteria:
Inclusion Criteria

* Admitted to the NICU at CMKC or KUMC
* With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist

Exclusion Criteria

• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed
Effect of Hypnosis on Motor Cortex Excitability

This study is intended to investigate neurophysiological mechanisms of hypnosis using transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in healthy volunteers under hypnosis.


Eligibility Criteria:
Inclusion Criteria: .

1. Healthy volunteers aged 20 to 45 years.
2. Hypnotisability above 14 as measured by the Tellegan absorption scale.

Exclusion Criteria:

1. Psychiatric diagnosis in axis I or axis II;
2. Documented history of head injury or seizure disorder;
3. Evidence of a disorder which could affect peripheral and central conduction such as multiple sclerosis, motor neuron disease, carpal tunnel syndrome, cervical spondylosis, diabetic neuropathy.
4. Any other contraindication to TMS as specified in the safety guidelines for rTMS (Wassermann, 1998) such as cardiac pacemakers or metallic deep brain electrodes.
5. Chronic pharmacological treatment.
Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.


Eligibility Criteria:
Patient who have given written informed consent to participate in the study, after having understood it

Inclusion Criteria:

* Scheduled for non-acute hand surgery in regional anesthesia
* Scheduled for surgery on one of the following: 1) Antebrachium fractures or 2) Arthroplasty of a thumb base joint or 3) alloplasty of a thumb base joint

Exclusion Criteria:

* BMI \> 40 kg/m2
* Weight \< 60 kg
* Age \< 18 years
* ASA physical status classification system grade \> 3
* Allergy to experimental drugs
* Patients who cannot cooperate with the examinations or treatment
* Patients who do not understand or speak Danish
* Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where surgery is required
Impact of nrTMS Therapy on the Progress of Neurorehabilitation

Low-frequency navigated repetitive transcranial magnetic stimulation (nrTMS) of the non-damaged hemisphere to increase cortical excitability of the damaged hemisphere and to reduce the increased neuronal inhibition in patients suffering from new surgery-related paresis after brain tumor resection

Postoperative loss of motor function greatly impairs the patients' quality of life and life expectancy of patients with brain tumors is significant limited. Hence the reduction of time spent on neurorehabilitation is very important.

Inclusion of patients that underwent brain tumor resection with a surgery-related paresis of the upper extremity.

Randomized controlled and double blinded trial - 2/3 nrTMS, 1/3 sham. Fifteen minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days: nrTMS group or sham group. Thirty minutes physical therapy of the upper extremity in both groups.

MRI, nTMS motor mapping, assessments for motor status of upper extremity including Fugl-Meyer-Assessment (FMA), National Institution of Health Stroke Scale (NIHSS), Jebsen Taylor Hand Function Test (JTHFT), Nine Hole Peg Test (NHPT), and Karnofsky Performance Scale (KPS) postoperatively, after the 7th day of intervention and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* New surgery-related paresis of upper extremity after brain tumor resection
* Written informed consent for participation

Exclusion Criteria:

* Contraindications for MRI
* Contraindications for nrTMS
* Only biopsy instead of tumor resection
* Patients without preserved MEP response as measured by postoperative nTMS motor mapping
Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

The investigators compare two strata of vaccinated patients: those recently vaccinated and those vaccinated more than two years ago. The primary objective is to compare pneumonia rates between the groups. As exploratory objectives, the investigators will describe the anti-pneumococcal antibody titers in hemodialysis patients as a function of time since vaccination, and determine factors influencing antibody kinetics. Further exploratory objectives investigate the relationship between antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolate a possible cut-off for protection from pneumonia.

Participating sites will screen all hemodialysis patients at their outpatient dialysis clinic for eligibility. Eligible patients will be approached and informed by their treating physician. If a patient agrees to participate in the study and to sign an informed consent form, basic data regarding vaccination history, underlying disease, etc. will be entered or electronically imported into the study eCRF. Pneumococcal antibody titers will be drawn at baseline and every 3 months. For newly vaccinated patients baseline titers will be drawn 4 weeks after the vaccination. DZIF CTUs will coordinate titer assessment schedules and inform the participating physicians of upcoming blood samplings. The samples will be taken on dialysis days and thus constitute only a minimal additional burden for both patients and physicians. DZIF CTUs will actively follow up on study patients for 2 years after enrolment. This follow-up will include validation of all hospitalizations and deaths documented in an electronic registry database to assess whether the primary endpoint (pneumonia) occurred. Additionally, dialysis units will be contacted every 6 months to assess if pneumonia occurred, which did not require hospitalization. DZIF CTUs will document titer assessment results in the eCRF. Titers will not be disclosed to the attending physicians because revaccination due to knowledge of titers would produce bias. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (e.g. RKI STIKO recommendations).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form including enrolment in registry database (QiN-registry)
* Patients with stage 5 chronic kidney disease treated with chronic hemodialysis
* Patients who are either already vaccinated or eligible and willing to be vaccinated against pneumococcal infection in accordance with current STIKO recommendations
* Age of 18 years or older

Exclusion Criteria:

* Patients unwilling/ineligible for vaccination under current STIKO recommendations
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt

The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms in Egypt.

Prevalence of Gastroesophageal reflux disease (GERD) in patients with upper gastrointestinal tract symptoms in Egypt

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* Attending the medical office and reporting symptoms suggestive of upper gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain, bloating, belching and nausea/vomiting.

Exclusion Criteria:

* Participating on a clinical trial during the last 3 months.
* Patients not able to read and/or understand the GERD-Q questionnaire.
* Patients already included in the study in other participating site.
* Patients taking PPIs or H2blockers in the l
Lutein Influence on Macula of Persons Issued From Amd Parents

Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina (named macula) and is the leading cause of blindness in industrialized countries. There is growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin) of dietary origin, which specifically accumulate in the macula, where they form the macular pigment. A first step towards the demonstration of a preventive effect of macular pigment for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on their plasma and retinal concentrations.

The objective of this study is to estimate the efficiency of a nutritonal supplementation with lutein and zeaxanthin to increase their plasma concentration and the density of macular pigment, in subjects at high genetic risk for AMD (1st generation stemming from parent affected by DMLA). This study is a multicentric, double blind, randomized clinical trial of supplementation versus placebo

Eligibility Criteria:
Inclusion Criteria:

* Men or women 40 to 70 years old
* Presenting histories of wet AMD with their father or their mother or 2
* Visual acuity of 20/25 or better (ETDRS)
* The presence of a AMD in one eye is possible
* Enlightened consent writes, dated and signed by the participant and the investigator above all examination required by the research.
* Subject agreeing to be registered in the national file
* Affiliated or profitable subject of a national insurance scheme

Exclusion Criteria:

* Presence of signs of AMD in both eyes (if AMD in one eye, inclusion for the other eye is possible)
* Histories of the other evolutionary eye pathologies susceptible to complicate the evaluation of the AMD and of the visual acuity (severe glaucoma, strong nearsightedness (superior or more equal in - 6 dioptres), the other severe rétinopathie)
* Subject with history of cataract surgery
* Opaqueness preventing the evaluation of the photos of the retina (cataract, corneal dystrophy)
* Supplementation with food complements in the year which precedes (cf. appendix 2 of the protocol)
* Participation in another clinical trial during 30 days which precede
* Subjects not compliants
* Subjects not flatware by the system of social security
* Subjects under guardianship judicial